FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart C—Monitoring Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—Cardiovascular Therapeutic Devices
CFR Sub-Part
Subpart F—Neurological Therapeutic Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
BRW
Protector, Dental
1
Product Code
BSF
Absorber, Carbon-Dioxide
1
Product Code
BSJ
Mask, Gas, Anesthetic
1
Product Code
BSK
Cuff, Tracheal Tube, Inflatable
2
Product Code
BSN
Filter, Conduction, Anesthetic
2
Product Code
BSO
Catheter, Conduction, Anesthetic
2
Product Code
BSP
Needle, Conduction, Anesthetic (W/Wo Introducer)
2
Product Code
BSR
Stylet, Tracheal Tube
1
Product Code
BSZ
Gas-Machine, Anesthesia
2
Product Code
BTB
Hook, Ether
1
Product Code
BTC
Bag, Reservoir
1
Product Code
BTK
Strap, Head, Gas Mask
1
Product Code
BTL
Ventilator, Emergency, Powered (Resuscitator)
2
Product Code
BTM
Ventilator, Emergency, Manual (Resuscitator)
2
Product Code
BTO
Tube, Tracheostomy (W/Wo Connector)
2
Product Code
BTP
Dropper, Ether
1
Product Code
BTQ
Airway, Nasopharyngeal
1
Product Code
BTR
Tube, Tracheal (W/Wo Connector)
2
Product Code
BTS
Tube, Bronchial (W/Wo Connector)
2
Product Code
BTT
Humidifier, Respiratory Gas, (Direct Patient Interface)
2
Product Code
BWB
Forceps, Tube Introduction
1
Product Code
BWC
Needle, Emergency Airway
2
Product Code
BWF
Spirometer, Therapeutic (Incentive)
2
Product Code
BWL
Apparatus, Electronanesthesia
3
Product Code
BYD
Condenser, Heat And Moisture (Artificial Nose)
1
Product Code
BYE
Attachment, Breathing, Positive End Expiratory Pressure
2
Product Code
BYF
Mask, Oxygen, Low Concentration, Venturi
1
Product Code
BYG
Mask, Oxygen
1
Product Code
BYH
Drain, Tee (Water Trap)
1
Product Code
BYI
Percussor, Powered-Electric
2
Product Code
BYJ
Unit, Liquid-Oxygen, Portable
2
Product Code
BYK
Tent, Oxygen, Electrically Powered
2
Product Code
BYL
Tent, Oxygen
1
Product Code
BYN
Chair, Posture, For Cardiac And Pulmonary Treatment
1
Product Code
BYO
Bottle, Blow
1
Product Code
BYP
Mouthpiece, Breathing
1
Product Code
BYT
Ventilator, External Body, Negative Pressure, Adult (Cuirass)
2
Product Code
BYW
Device, Rebreathing
1
Product Code
BYX
Tubing, Pressure And Accessories
1
Product Code
BZA
Connector, Airway (Extension)
1
Product Code
BZB
Catheter, Nasal, Oxygen
1
Product Code
BZD
Ventilator, Non-Continuous (Respirator)
2
Product Code
BZE
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
2
Product Code
BZO
Set, Tubing And Support, Ventilator (W Harness)
1
Product Code
BZR
Mixer, Breathing Gases, Anesthesia Inhalation
2
Product Code
CAD
Vaporizer, Anesthesia, Non-Heated
2
Product Code
CAE
Airway, Oropharyngeal, Anesthesiology
1
Product Code
CAF
Nebulizer (Direct Patient Interface)
2
Product Code
CAG
Circulator, Breathing-Circuit
2
Product Code
CAI
Circuit, Breathing (W Connector, Adaptor, Y Piece)
1
Product Code
CAL
Laryngoscope, Non-Rigid
1
Product Code
CAO
Airway, Esophageal (Obturator)
2
Product Code
CAT
Cannula, Nasal, Oxygen
1
Product Code
CAW
Generator, Oxygen, Portable
2
Product Code
CAZ
Anesthesia Conduction Kit
2
Product Code
CBF
Chamber, Hyperbaric
2
Product Code
CBG
Spreader, Cuff
1
Product Code
CBH
Device, Fixation, Tracheal Tube
1
Product Code
CBI
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
2
Product Code
CBK
Ventilator, Continuous, Facility Use
2
Product Code
K
24
1520
Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask; Veraseal 3 Full Face Non-Vented Mask; Veraseal 3 Full Face AAV Non-Vented Mask
2
Cleared 510(K)
K
23
2365
Vivo 45 LS
2
Cleared 510(K)
K
23
1778
Nihon Kohden NKV-550 Series Ventilator System
2
Cleared 510(K)
K
21
3098
Panther 5
2
Cleared 510(K)
K
22
0107
Mindray SV600 Ventilator, Mindray SV800 Ventilator
2
Cleared 510(K)
K
22
2644
Nihon Kohden NKV-440 Ventilator System
2
Cleared 510(K)
K
22
2207
Babylog VN800, Babylog VN600
2
Cleared 510(K)
K
22
2024
Evita V800, Evita V600
2
Cleared 510(K)
K
20
1082
LTV2 Series Ventilators
2
Cleared 510(K)
K
21
0384
CARESCAPE R860
2
Cleared 510(K)
K
20
1874
Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1
2
Cleared 510(K)
K
20
3449
F&P Visairo NIV Mask Range
2
Cleared 510(K)
K
20
1306
HAMILTON-C3
2
Cleared 510(K)
K
20
2970
Ventway Sparrow
2
Cleared 510(K)
K
20
1658
Hamilton-C6
2
Cleared 510(K)
K
19
3056
Puritan Bennett 980 Series Ventilator System
2
Cleared 510(K)
K
19
2604
Servo-air 4.0 Ventilator System
2
Cleared 510(K)
K
19
3228
Hamilton-G5
2
Cleared 510(K)
K
19
2307
Nihon Kohden NKV-550 Series Ventilator System
2
Cleared 510(K)
K
18
3364
Bellavista
2
Cleared 510(K)
K
18
1216
HAMILTON-T1, HAMILTON-C1
2
Cleared 510(K)
K
18
0295
Hamilton-G5
2
Cleared 510(K)
K
19
0533
Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Vented Mask, Veraseal 3 Full Face AAV Non-Vented
2
Cleared 510(K)
K
18
1170
Trilogy Evo Universal
2
Cleared 510(K)
K
18
1166
Trilogy Evo
2
Cleared 510(K)
K
18
0098
SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1
2
Cleared 510(K)
K
18
0779
Savina 300
2
Cleared 510(K)
K
18
1695
Nihon Kohden NKV-550 Series Ventilator System
2
Cleared 510(K)
K
17
3973
TV-100
2
Cleared 510(K)
K
17
2875
Astral 100/150
2
Cleared 510(K)
K
17
3060
F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version
2
Cleared 510(K)
K
16
2738
Puritan Bennett 980 Ventilator System
2
Cleared 510(K)
K
17
0037
Breathe Technologies Life2000™ Ventilation System
2
Cleared 510(K)
K
16
2832
731 Series Ventilators
2
Cleared 510(K)
K
16
3127
bellavista 1000
2
Cleared 510(K)
K
16
1450
HAMILTON-C3
2
Cleared 510(K)
K
16
2877
VOCSN Unified Respiratory System
2
Cleared 510(K)
K
15
3046
HAMILTON-MR1
2
Cleared 510(K)
K
15
2068
Astral 100/150
2
Cleared 510(K)
K
14
3035
Flight 60 Ventilator
2
Cleared 510(K)
K
15
1252
Puritan Bennett 840 Series Ventilator System
2
Cleared 510(K)
K
15
1814
SERVO-U Ventilator System, SERVO-n Ventilator System
2
Cleared 510(K)
K
15
1901
AirView
2
Cleared 510(K)
K
15
0638
AF541 SE Full Face Mask
2
Cleared 510(K)
K
14
0939
HAMILTON-T1,HAMILTON-C1
2
Cleared 510(K)
K
14
2679
CARESCAPE R860
2
Cleared 510(K)
K
14
1943
BREATHE TECHNOLOGIES LIFE2000 VENTILATION SYSTEM
2
Cleared 510(K)
K
14
0575
ENGSTROM CARESTATION, ENGSTROM PRO
2
Cleared 510(K)
K
12
1886
SAVINA 300 SAVINA 300, COUNTRY VARIANTS
2
Cleared 510(K)
K
12
3149
SERVO-I VENTILATOR SYSTEM
2
Cleared 510(K)
K
13
3868
ASTRAL VENTILATOR
2
Cleared 510(K)
K
13
0171
FLIGHT 60 VENTILATOR
2
Cleared 510(K)
K
13
1252
PURITAN BENNETT 980 SERIES VENTILATOR SYSTEM
2
Cleared 510(K)
K
12
2438
HAMILTON-MR1
2
Cleared 510(K)
K
13
0178
INSPIRATION VENTILATOR SYSTEM 5I/7I
2
Cleared 510(K)
K
13
1774
HAMILTON-G5
2
Cleared 510(K)
K
12
0931
CRITICAL CARE VENTILATOR
2
Cleared 510(K)
K
12
2560
VERSALVENT MODEL V1 HYPERBARIC CHAMBER VENTILATOR MODEL V1
2
Cleared 510(K)
K
12
3637
HAMILTON-C3
2
Cleared 510(K)
K
11
3743
EVOLUTION 3E VENTILATOR
2
Cleared 510(K)
K
12
0146
QUARK SERIES
2
Cleared 510(K)
K
12
1225
HAMILTON-C2
2
Cleared 510(K)
K
12
1891
NEWPORT AURA VENTILATOR
2
Cleared 510(K)
K
12
1379
PNEUTON MINI VENTILATOR PNEUTON MINI NON-INVASIVE VENTILATION (NIV) KIT ACCESSORY
2
Cleared 510(K)
K
12
0639
PERFORMAX PEDIATRIC SE TOTAL FACE MASK
2
Cleared 510(K)
K
12
0726
FLIGHT 60 VENTILATOR
2
Cleared 510(K)
K
11
2754
IVENT101
2
Cleared 510(K)
K
11
2729
BLEASE700/900 SERIES VENTILATORS
2
Cleared 510(K)
K
12
0574
HAMILTON-C1
2
Cleared 510(K)
K
12
0670
HAMILTON-T1
2
Cleared 510(K)
K
11
3051
SPACELABS ARKON ANESTHESIA WORKSTATION
2
Cleared 510(K)
K
11
1473
UNI-VENT (R) MODEL 731 SERIES PORTABLE CRITICAL CARE VENTILATOR
2
Cleared 510(K)
K
11
2006
HAMILTON-TC1
2
Cleared 510(K)
K
11
1595
NEUMOVENT GRAPHNET
2
Cleared 510(K)
K
11
0083
V200 VENTILATOR WITH APRV MODE, ESPRIT VENTILATOR WITH APRV MODE
2
Cleared 510(K)
K
11
1146
NEWPORT HT70 VENTILATOR
2
Cleared 510(K)
K
10
3803
HAMILTON-G5
2
Cleared 510(K)
K
11
1683
FLIGHT 60 VENTILATOR
2
Cleared 510(K)
K
11
1610
TRILOGY SERIES VENTILATOR WITH OXIMETRY
2
Cleared 510(K)
K
10
3625
OXYLOG 3000 PLUS WORKSTATION, OXYLOG 3000 PLUS BASIC DEVICE
2
Cleared 510(K)
K
11
1116
ENGSTROM CARESTATION, ENGSTROM PRO, MODELS 1505-9000-000, 1505-9003-000
2
Cleared 510(K)
K
11
0795
V200 INTELLI-TRAK OPTION
2
Cleared 510(K)
K
10
2120
NIPPV SILICONE FACE MASK, NIPPV ECONOMY FACE MASK, NIPPV SILICONE NASAL MASK MODEL 10212, 10222, 10202
2
Cleared 510(K)
K
10
3211
AVEA VENTILATOR
2
Cleared 510(K)
K
10
3318
UNI-VENT 731 SERIES MODEL EMV+ PORTABLE CRITICAL CARE VENTILATOR
2
Cleared 510(K)
K
10
1850
SPACELABS BLEASESIRIUS ANESTHESIA WORKSTATION
2
Cleared 510(K)
K
10
1643
MODEL LTV 1100 VENTILATOR
2
Cleared 510(K)
K
10
2775
HAMILTON-C2
2
Cleared 510(K)
K
10
2054
V200 VENTILATOR
2
Cleared 510(K)
K
10
1401
NEUMOVENT GRAPHNET MODEL 3179L1V
2
Cleared 510(K)
K
10
1129
ESPRIT VENTILATOR WITH AF531 SE FULL FACE MASK
2
Cleared 510(K)
K
10
1803
NEWPORT E360 VENTILATOR
2
Cleared 510(K)
K
10
0753
FLIGHT 60 VENTILATOR, MODEL F-60
2
Cleared 510(K)
K
09
3905
TRILOGY 202 VENTILATOR
2
Cleared 510(K)
K
09
3094
VELA VENTILATOR
2
Cleared 510(K)
K
09
3886
ENGSTROM CARESTATION, ENGSTROM PRO
2
Cleared 510(K)
K
09
3632
INFINITY ACUTE CARE SYSTEM WORKSTATION NEONATAL CARE
2
Cleared 510(K)
K
09
3633
INFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CARE
2
Cleared 510(K)
K
09
2847
840 VENTILATOR SYSTEM WITH EXPANDED NEOMODE OPTION
2
Cleared 510(K)
K
09
2148
HAMILTON-C2
2
Cleared 510(K)
K
09
3416
TRILOGY 200 VENTILATOR
2
Cleared 510(K)
K
09
2263
ENDURAVENT-5 VENTILATOR
2
Cleared 510(K)
K
09
2648
RESPIRONICS PERFORMAX SE TOTAL FACE MASK
2
Cleared 510(K)
K
09
2264
ATLANTIS HYPERBARIC CHAMBER VENTILATOR
2
Cleared 510(K)
K
09
2135
MODIFICATION TO IVENT 101
2
Cleared 510(K)
K
09
0888
NEWPORT HT70 FAMILY OF VENTILATORS
2
Cleared 510(K)
K
09
1238
UNI-VENT-731 SERIES VENTILATORS, MODEL 731EMV+
2
Cleared 510(K)
K
09
0468
HAMILTON-C2
2
Cleared 510(K)
K
08
3693
PB 840 VENTILATOR SYSTEM WITH LEAK COMPENSATION OPTION, MODEL 840
2
Cleared 510(K)
K
08
3688
PULMONETIC SYSTEMS LTV 1200 MR CONDITIONAL VENTILATOR
2
Cleared 510(K)
K
08
1845
IVENT101
2
Cleared 510(K)
K
08
3526
TRILOGY 100 VENTILATOR
2
Cleared 510(K)
K
08
3122
HOSPITAL FULL FACE MASK NON VENTED, MODEL: RT041
2
Cleared 510(K)
K
08
2351
NEPTUNE HYPERBARIC VENTILATOR
2
Cleared 510(K)
K
08
3050
EVITE XL
2
Cleared 510(K)
K
08
2724
NEWPORT HTS50 VENTILATOR WITH DUAL PAC BATTERY SYSTEM
2
Cleared 510(K)
K
07
1526
UNI-VENT 731 SERIES VENTILATORS, MODEL 731, 731EMV
2
Cleared 510(K)
K
08
2600
OXYLOG 2000 PLUS SYSTEM (MODEL 5705080), OXYLOG 2000 PLUS BASIC DEVICE (MODEL 5705082)
2
Cleared 510(K)
K
08
2966
PB 540 VENTILATOR
2
Cleared 510(K)
K
07
2926
HELONTIX VENT
2
Cleared 510(K)
K
08
1670
THE ADVANTAGE SERIES NON-VENTED (NV) FULL FACE MASK
2
Cleared 510(K)
K
08
1842
ENGSTROM CARESTATION, ENGSTROM PRO
2
Cleared 510(K)
K
08
1521
MODIFICATION TO HAMILTON-G5
2
Cleared 510(K)
K
08
1743
CLASSICSTAR NV SE AND NOVASTAR NV SE AND AAV FULL FACE MASKS
2
Cleared 510(K)
K
08
1837
AVEA VENTILATOR
2
Cleared 510(K)
K
08
0181
MODIFICATION TO GALILEO GOLD
2
Cleared 510(K)
K
07
3179
SERVO-I VENTILATOR SYSTEM MODEL 64 87 800 E4073, HELIOX OPTION, MODEL 6675585
2
Cleared 510(K)
K
07
3694
IVENT 2001 MRI CONDITIONAL
2
Cleared 510(K)
K
07
2885
CARINA SYSTEM, MODEL 8419350; CARINA BASIC DEVICE, MODEL 5704110
2
Cleared 510(K)
K
07
2412
OPTION SMARTCARE FOR EVITAXL,SMARTCARE KIT CAPNO PACKAGE, CO2 SENSOR CAPNOSMART, MODELS 8415941, 8415942, 6871500
2
Cleared 510(K)
K
07
3069
MODIFICATION TO AVEA VENTILATOR
2
Cleared 510(K)
K
07
2590
INSPIRATION; VENTILATOR SYSTEM, LS VENTILATOR SYSTEM, INFANT VENTILATOR SYSTEM AND INFANT LS VENTILATOR SYSTEM
2
Cleared 510(K)
K
07
2588
PERFORMAX SE TOTAL FACE MASK
2
Cleared 510(K)
K
07
0899
PURITAN BENNETT LEGENDAIR XL2
2
Cleared 510(K)
K
07
2450
ESPRIT VENTILATOR AUTO-TRAK SENSITIVITY OPTION, MODEL V1000
2
Cleared 510(K)
K
07
0513
HAMILTON-G5
2
Cleared 510(K)
K
07
1194
RAPHAEL COLOR ASV VENTILATOR
2
Cleared 510(K)
K
07
0594
PALMTOP VENTILATOR, MODELS PTV-8, PTV-10
2
Cleared 510(K)
K
07
1212
ESPRIT VENTILATOR SPEAKING MODE OPTION, MODEL V1000
2
Cleared 510(K)
K
06
3806
SLEEPNET MOJO -NV FULL FACE MASK, NON-VENTED
2
Cleared 510(K)
K
06
3650
VENTILATOR WITH RESPIRATORY MECHANICS, MODEL 840
2
Cleared 510(K)
K
06
3404
SERVO-I VENTILATOR SYSTEM, MODELS 64, 87 AND 800
2
Cleared 510(K)
K
06
2793
SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E; NAVA OPTION
2
Cleared 510(K)
K
06
2710
GE DATEX-OHMEDA ENGSTROM CARESTATION
2
Cleared 510(K)
K
06
2267
OXYLOG 3000
2
Cleared 510(K)
K
06
2093
AVEA VENTILATOR
2
Cleared 510(K)
K
06
2019
RESPCARE HYBRID NE FACE MASK, MODEL TBD,; DISPOSABLE, MODEL TBD
2
Cleared 510(K)
K
06
1094
NEWPORT E500 WAVE VENTILATOR
2
Cleared 510(K)
K
06
1090
GALILEO GOLD ASV
2
Cleared 510(K)
K
06
1627
MODIFICATION TO I VENT 201
2
Cleared 510(K)
K
06
0705
CARINA HOME
2
Cleared 510(K)
K
06
0862
GE DATEX-OHMEDA ENGSTROM CARESTATION
2
Cleared 510(K)
K
06
0647
LTV 1200 VENTILATOR
2
Cleared 510(K)
K
06
0549
AUTOMOBILE LIGHTER POWER CORD
2
Cleared 510(K)
K
05
3388
MODEL 840 VENTILATOR WITH PROPORTIONAL ASSIST VENTILATION PLUS SOFTWARE OPTION
2
Cleared 510(K)
K
05
3270
IVENT 201
2
Cleared 510(K)
K
05
3502
NEWPORT E360 VENTILATOR
2
Cleared 510(K)
K
05
2863
RAPHAEL COLOR
2
Cleared 510(K)
K
05
1895
GE DATEX-OHMEDA ENGSTROM CARESTATION
2
Cleared 510(K)
K
05
2554
MODIFICATION TO: IVENT 201 PORTABLE VENTILATOR
2
Cleared 510(K)
K
05
1222
AV-S ANAESTHESIA VENTILATOR
2
Cleared 510(K)
K
05
1767
LTV 1000 VENTILATOR
2
Cleared 510(K)
K
05
1550
INSPIRATION VENTILATOR SYSTEM
2
Cleared 510(K)
K
05
1263
EVITAXL WITH OPTION SMARTCARE
2
Cleared 510(K)
K
05
1262
ESPRIT VENTILATOR NEONATAL OPTION, MODEL V1000
2
Cleared 510(K)
K
05
0860
GE DATEX-OHMEDA CENTIVA/5 VENTILATOR
2
Cleared 510(K)
K
05
0597
GE DATEX-OHMEDA ENGSTROM CARESTATION
2
Cleared 510(K)
K
04
3085
MODIFICATION TO: PNEUTON VENTILATOR
2
Cleared 510(K)
K
04
2468
IVENT 201 PORTABLE VENTILATOR
2
Cleared 510(K)
K
04
0574
GALILEO GOLD
2
Cleared 510(K)
K
04
1775
GE DATEX-OHMEDA ENGSTROM CARESTATION
2
Cleared 510(K)
K
03
2922
CLARISSA INFANT NCPAP CANNULA
2
Cleared 510(K)
K
04
1524
GE DATEX-OHMEDA HELIOX DELIVERY SYSTEM
2
Cleared 510(K)
K
04
1223
MODIFICATION TO SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E
2
Cleared 510(K)
K
04
1412
ESPRIT VENTILATOR WITH NICO-ESPRIT INTERFACE OPTION, MODEL V1000
2
Cleared 510(K)
K
04
0790
MODIFICATION TO LTV 1000 VENTILATOR/BREATHING CIRCUITS
2
Cleared 510(K)
K
04
0642
LPO OPTION FOR DRAGER INTENSIVE CARE VENTILATOR SAVINA
2
Cleared 510(K)
K
04
0540
MODIFICATION TO LTV 1000 VENTILATOR
2
Cleared 510(K)
K
03
2451
BIRD TBIRD VELA VENTILATOR
2
Cleared 510(K)
K
04
0221
SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E
2
Cleared 510(K)
K
03
0780
NEWPORT E500 WAVE VENTILATOR
2
Cleared 510(K)
K
03
4040
ESPRIT VENTILATOR, MODEL V1000
2
Cleared 510(K)
K
03
0341
MODIFICATION TO INSPIRATION VENTILATOR SYSTEM
2
Cleared 510(K)
K
02
2679
RAPHAEL
2
Cleared 510(K)
K
03
2226
LTV-1000 VENTILATOR
2
Cleared 510(K)
K
02
3366
DATEX-OHMEDA 7900 VENTILATOR ENHANCEMENTS
2
Cleared 510(K)
K
02
4344
PNEUTON VENTILATOR
2
Cleared 510(K)
K
03
0515
HANS RUDOLPH 7500 SERIES REUSABLE ORO-NASAL NIV MASKS
2
Cleared 510(K)
K
02
3289
OPTION NIV, MODEL 8414115, UPGRADE KIT NIV, MODEL 8414072
2
Cleared 510(K)
K
02
3135
IMAGE3 SE DISPOSABLE FULL FACE MASK
2
Cleared 510(K)
K
01
2691
MONSOON CRITICAL CARE JET VENTILATOR AND ACCESSORIES
2
Cleared 510(K)
K
02
1112
INSPIRATION VENTILATOR SYSTEM
2
Cleared 510(K)
K
02
3350
ESPRIT VENTILATOR WITH RESPIRATORY MECHANICS
2
Cleared 510(K)
K
02
2674
BIRD AVEA VENTILATOR
2
Cleared 510(K)
K
02
2132
SERVO VENTILATOR SYSTEM, MODEL 64 87 800 E407E
2
Cleared 510(K)
K
02
1573
PURITAN-BENNETT 840 VENTILATIOR SYSTEM WITH VOLUME VENTILATION PLUS OPTION
2
Cleared 510(K)
K
01
2693
MISTRAL CRITICAL CARE JET VENTILATOR AND ACCESSORIES
2
Cleared 510(K)
K
01
3642
AVEA
2
Cleared 510(K)
K
02
0746
BIRD TBIRD VELA VENTILATOR
2
Cleared 510(K)
K
01
0793
OXYLOG 1000, MODEL 2M86840
2
Cleared 510(K)
K
01
0925
SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E
2
Cleared 510(K)
K
01
2177
VENTVIEW, MODEL 8414095
2
Cleared 510(K)
K
01
0317
AV 800 VENTILATOR
2
Cleared 510(K)
K
01
1957
IVENT 201 PORTABLE VENTILATOR
2
Cleared 510(K)
K
00
3068
SAVINA
2
Cleared 510(K)
K
01
0093
NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 474
2
Cleared 510(K)
K
01
0608
MODIFICATION TO LAP TOP VENTILATOR (LTV)
2
Cleared 510(K)
K
00
3770
BIRD TBIRD LEGACY VENTILATOR
2
Cleared 510(K)
K
00
2951
MAGELLAN VENTILATOR
2
Cleared 510(K)
K
00
1646
PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTION
2
Cleared 510(K)
K
00
2686
ACHIEVA VENTILATOR Y-ACH+E, ACHIEVA PS VENTILATOR Y-ACHPS+E, ACHIEVA PSO2 VENTILATOR Y-ACHPS02+E
2
Cleared 510(K)
K
00
2881
VENTILATOR, CONTINUOUS (RESPIRATOR), MODEL LTV 1000
2
Cleared 510(K)
K
99
2133
NEWPORT HT50 VENTILATOR WITH HUMIDIFIER HT50-H, NEWPORT HT50 VENTILATOR WITHOUT HUMIDIFIER, HT50-H1, NEWPORT HT50 VENTIL
2
Cleared 510(K)
K
00
1686
GALILEO VENTILATOR
2
Cleared 510(K)
K
00
1208
ESPIRT
2
Cleared 510(K)
K
99
3449
BIRD V.I.P. GOLD/STERLING
2
Cleared 510(K)
K
99
3071
PURITAN-BENNETT VENTILATOR SYSTEM WITH ET/TRACHEOSTOMY TUBE COMPENSATION, TC, OPTION, MODEL 840
2
Cleared 510(K)
K
99
0177
NELLCOR PURITAN BENNETT ACHIEVA VENTILATOR AND REPORT GENERATOR
2
Cleared 510(K)
K
99
3167
MILLENNIUM INFANT VENTILATOR
2
Cleared 510(K)
K
97
2833
E100M VENTILATOR (E100M)
2
Cleared 510(K)
K
99
2670
OXYGEN ENRICHMENT KIT, MODELS SG 066, SG 067
2
Cleared 510(K)
K
99
2788
BEAR CUB 750 PSV
2
Cleared 510(K)
K
98
2910
HAMILTON MEDICAL GALILEOVENTILATOR
2
Cleared 510(K)
K
99
2608
ATC OPTION FOR EVITA 2 DURA AND EVITA 4
2
Cleared 510(K)
K
98
2132
BLEASE 6200 ANAESTHESIA VENTILATOR
2
Cleared 510(K)
K
98
4056
LTV 1000
2
Cleared 510(K)
K
98
1668
SMARTVENT 201 PORTABLE VENTILATOR
2
Cleared 510(K)
K
99
0429
MODIFICATION OF VENTURI VENTILATOR
2
Cleared 510(K)
K
98
4577
DRAGER OXYLOG 2000
2
Cleared 510(K)
K
98
4535
PURITAN-BENNETT 840 VENTILATORY SYSTEM WITH BILEVEL OPTION
2
Cleared 510(K)
K
98
4379
NELLCOR PURITAN BENNETT, 760 VENTILATOR SYSTEM
2
Cleared 510(K)
K
98
3219
NEOFLOW OPTION MODEL NUMBERS 8413563, 8411900
2
Cleared 510(K)
K
98
1412
M1145 (UPS1-1.25K-1G-MP) UPS
2
Cleared 510(K)
K
98
3981
BEAR 1000, VEOLAR W LEONARDO GRAPHICS, BICORE CP-2000, BICORE CP-100, HI-LO JET ET TUBE
2
Cleared 510(K)
K
98
1072
ESPRIT VENTILATOR
2
Cleared 510(K)
K
98
1371
LTV 1000 VENTILATOR
2
Cleared 510(K)
K
98
2580
BIRD MONITOR INTERFACE
2
Cleared 510(K)
K
98
0642
EVITA 4 (8411900)
2
Cleared 510(K)
K
98
1971
TBIRD VS/AVS VOLUME VENTILATOR, MODELS 15568, 15570 , LP10 VOLUME VENTILATOR WITH PRESSURE LIMIT MODEL 00-004130, BEAR 3
2
Cleared 510(K)
K
98
0208
DIVAN ANESTHESIA VENTILATOR
2
Cleared 510(K)
K
98
2174
VENTURI VENTILATOR
2
Cleared 510(K)
K
97
4176
BABYLOG 8000 PLUS
2
Cleared 510(K)
K
97
0460
NELLCOR PURITAN BENNETT, 840 VENTILATOR SYSTEM (MODEL 840)
2
Cleared 510(K)
K
97
0158
BABYPAC
2
Cleared 510(K)
K
96
4540
NELLCOR PURITAN BENNETT, 740 VENTILATOR SYSTEM
2
Cleared 510(K)
K
97
2203
BABYBIRD VENTILATOR, PORTABLE LIFECARE VENTILATOR, EXTERNAL PRESSURE LIMITER, VOLUME VENTILATOR WITH PRESSURE LIMIT
2
Cleared 510(K)
K
97
0839
SERVO VENTILATOR 300A
2
Cleared 510(K)
K
97
2248
NELLCOR PURITAN BENNETT GEMINI
2
Cleared 510(K)
K
97
0165
EVITA 2 DURA
2
Cleared 510(K)
K
96
4543
INFRASONICS ADULT VENTILATOR TRENDING OPTION
2
Cleared 510(K)
K
96
1687
EVITA 4
2
Cleared 510(K)
K
95
0853
OPTIONAL DISPLAY AND SOFTWARE FOR DRAGER VENTILATORS
2
Cleared 510(K)
K
96
0168
SIEMENS SERVO SCREEN 390 AND SERVO COMPUTER MODULE 990
2
Cleared 510(K)
K
96
0010
SERVO VENTILATOR 300 COMPUTER INTERFACE
2
Cleared 510(K)
K
96
0964
OHMEDA 7900 ANESTHESIA VENTILATOR
2
Cleared 510(K)
K
95
3238
DRAGER MICRO VENT
2
Cleared 510(K)
K
96
0861
OMICRON MONITOR, DELTA MONITOR
2
Cleared 510(K)
K
95
5865
BEAR CUB INFANT PRESSURE VENTILATOR
2
Cleared 510(K)
K
95
2880
MODEL LP-1000 VOLUME VENTILATOR
2
Cleared 510(K)
K
95
0484
TBIRD VS VENTILATOR AND TBIRD AVS VENTILATOR
2
Cleared 510(K)
K
95
3228
NARKOMED AV2+ ANESTHESIA VENTILATOR
2
Cleared 510(K)
K
94
3106
ADULT VENTILATOR
2
Cleared 510(K)
K
94
3412
VENTURI VENTILATOR
2
Cleared 510(K)
K
94
2938
CROSSVENT-4 VENTILATOR
2
Cleared 510(K)
K
94
3531
OXYLOG 2000
2
Cleared 510(K)
K
94
1308
NEWPORT ELECTRONIC MANOMETER
2
Cleared 510(K)
K
94
1309
NEWPORT ELECTRONIC MANOMETER
2
Cleared 510(K)
K
93
0017
PB 7200 SERIES VENTILATORY SYSTEM W/KEYBOARD
2
Cleared 510(K)
K
92
4043
AUTO-PEEP
2
Cleared 510(K)
K
92
2975
MODEL 7200AE VENTILATOR (ENHANCEMENT)
2
Cleared 510(K)
K
92
2705
MODEL 7200AE VENTILATOR
2
Cleared 510(K)
K
92
2102
PROPORTIONAL SOLENOID VALVE
2
Cleared 510(K)
K
92
6292
BABYLOG 8000 INFANT VENTILATOR
2
Cleared 510(K)
K
93
0747
BIRD 8400TI ADULT VOLUME VENTILATOR
2
Cleared 510(K)
K
92
4930
EVITA
2
Cleared 510(K)
K
93
3262
BIRD AVIAN PORT MILITARY VENT NSN 6530-01-374-8903
2
Cleared 510(K)
K
92
3992
POWER PACK 350/BATTERY PACK 351
2
Cleared 510(K)
K
92
1387
BIRD 8400ST ADULT VOLUME VENTILATOR
2
Cleared 510(K)
K
92
3444
SERVO GRAPHICS
2
Cleared 510(K)
K
92
0113
BIRD GRAPHICS MONITOR
2
Cleared 510(K)
K
92
0121
SECHRIST IV-100B SAVI SYSTEM
2
Cleared 510(K)
K
92
5262
MERIDIAN MEDICAL SYSTEMS VOLUME VENTILATOR CIRCUIT
2
Cleared 510(K)
K
92
2314
VENTILATOR INTERFACE 9291/4
2
Cleared 510(K)
K
92
2654
VENTILATOR ADULT STAR MODIFICATION
2
Cleared 510(K)
K
92
0002
MODEL 7200AE VENTILATOR FLOW BY 2.0 OR OPTION 50
2
Cleared 510(K)
K
92
1821
IBT MODEL SVI
2
Cleared 510(K)
K
91
4607
SEHRIST VOLUME VENTILATOR, MODEL 2200B
2
Cleared 510(K)
K
92
3809
PURITAN-BENNETT MODEL 7200AE VENTILATOR
2
Cleared 510(K)
K
92
3704
INFANT STAR SERIES 500
2
Cleared 510(K)
K
91
5488
PEDIATRIC VENTILATOR AND PARTNER VOLUME MONITOR
2
Cleared 510(K)
K
91
4424
MODEL 6213 REMOTE ALARM
2
Cleared 510(K)
K
92
2477
MODEL 105 VENTILATOR, MODIFICATION
2
Cleared 510(K)
K
91
5312
MODIFICATION PURITAN BENETT COMPANION 2801 VOL VEN
2
Cleared 510(K)
K
91
2619
BEAR 7 VENTILATOR
2
Cleared 510(K)
K
91
1804
INFRASONICS VENTILATOR ADULT STAR, MODIFICATION
2
Cleared 510(K)
K
92
1726
HAYEK OSCILLATOR, MODIFICATION
2
Cleared 510(K)
K
91
3423
LIFECARE REMOTE ALARM II
2
Cleared 510(K)
K
91
3972
STAR SYNC, MODIFICATION
2
Cleared 510(K)
K
90
1448
VEOLAR VENTILATOR
2
Cleared 510(K)
K
91
1336
BIRD NEBULIZATION SYNCHRONIZER
2
Cleared 510(K)
K
91
4485
VENTILATOR STAND
2
Cleared 510(K)
K
91
2533
NARKOMED AV-E VENTILATOR
2
Cleared 510(K)
K
91
1450
INFANT VENTILATOR
2
Cleared 510(K)
K
90
5234
TXP TRANSPORTER FAMILY AND RELATED ACCESSORIES
2
Cleared 510(K)
K
90
3089
BABYLOG 8000 INFANT VENTILATOR
2
Cleared 510(K)
K
91
0847
OHMEDA 7810 ANESTHESIA VENTILATOR
2
Cleared 510(K)
K
90
5235
VDR SINUSOIDAL PERCUSIONATOR FAMILY/RELATE ACCESS
2
Cleared 510(K)
K
90
0744
AMS 3000 PORTABLE JET VENTILATOR
2
Cleared 510(K)
K
90
0745
VS-200S JET VENTILATOR
2
Cleared 510(K)
K
90
2859
SERVO VENTILATOR 300
2
Cleared 510(K)
K
90
2405
MALLARD MEDICAL MODEL 2400 ANESTHESIA VENTILATOR
2
Cleared 510(K)
K
90
5272
ADULT STAR, MODIFICATION
2
Cleared 510(K)
K
90
2506
7200AE MICROPROCESSOR VENTILATOR W/ENHANCED HARD.
2
Cleared 510(K)
K
90
1953
AIROX AXR. 1A
2
Cleared 510(K)
K
89
5513
PERRY SV-1 HYPERBARIC VENTILATOR
2
Cleared 510(K)
K
90
5244
MODEL LP6 VENTILATOR, MODIFICATION
2
Cleared 510(K)
K
90
3010
CONTINUOUS VOLUME VENTILATOR MODEL LP10
2
Cleared 510(K)
K
90
0313
PERCUSSIONAIRE(R) VDR-3 IMV PERCUS/RESPIR 1250 MIN
2
Cleared 510(K)
K
90
0315
PERCUSSIONAIRE TXP TRANSPORTER/RESPIRATORS 750 MIN
2
Cleared 510(K)
K
90
0314
PERCUSSIONAIRE(R) OSCILLATRON-1 PERCUSS 1300 MIN
2
Cleared 510(K)
K
90
2084
OHMEDA 7800 ANESTHESIA VENTILATOR SOFTWARE UPDATE
2
Cleared 510(K)
K
90
1785
NEWPORT WAVE VENTILATOR MODEL E200
2
Cleared 510(K)
K
90
0637
BEAR CEM CONTROLLER
2
Cleared 510(K)
K
90
0465
MAX TRANSPORT VENTILATOR
2
Cleared 510(K)
K
89
6269
SECHRIST VOLUME VENTILATOR MODEL 2200B
2
Cleared 510(K)
K
89
6442
PPG BIOMEDICAL VENTILATOR MODEL IRISA
2
Cleared 510(K)
K
89
7113
PURITAN-BENNETT COMPANION 2801 VOLUME VENTILATOR
2
Cleared 510(K)
K
88
4389
MODIFIED 225/SIMV VOLUME VENTILATOR
2
Cleared 510(K)
K
89
5541
V.I.P. BIRD INFANT - PEDIATRIC VENTILATOR
2
Cleared 510(K)
K
89
6735
TYPE 9290 INTERFACE RESPIRATOR
2
Cleared 510(K)
K
89
6736
TYPE 9291 INTERFACE RESPIRATOR
2
Cleared 510(K)
K
89
6381
MVP-10 MRI INFANT VENTILATOR
2
Cleared 510(K)
K
89
6380
IC-2A MRI ADULT/PEDIATRIC VENTILATOR
2
Cleared 510(K)
K
89
4322
8400ST VOLUME VENTILATOR
2
Cleared 510(K)
K
89
3622
PREEMICARE MODEL 200-II INFANT TRANSPORT VENTIL.
2
Cleared 510(K)
K
89
5779
MODIFIED PERMCATH TRAY (2ND SUBMISSION)
2
Cleared 510(K)
K
89
2886
PERCUSSIONAIRE OSCILLATRON-1 MEDICAL RESPIRATOR
2
Cleared 510(K)
K
89
5486
BIRD (VDR) SINUSOIDAL PERCUSSIONATORS
2
Cleared 510(K)
K
89
4426
LEONARDO INFORMATION SYSTEM
2
Cleared 510(K)
K
89
4316
AMADEUS VENTILATOR
2
Cleared 510(K)
K
89
3786
SERVO ANESTHESIA CIRCLE 985
2
Cleared 510(K)
K
88
4832
PERCUSSIONAIRE RESPIRATORS (MULTIPLE)
2
Cleared 510(K)
K
89
3043
PURITAN-BENNETT 7200SPI MICROPROCESSOR VENTILATOR
2
Cleared 510(K)
K
88
3809
NEWPORT VENTILATOR MODEL E150
2
Cleared 510(K)
K
88
4793
ADVENT VENTILATOR
2
Cleared 510(K)
K
89
0921
DATA EXCHANGE SYSTEM, MODEL 24
2
Cleared 510(K)
K
88
4521
STAR SYNC
2
Cleared 510(K)
K
88
3865
EXTERNAL JET SYNCHRONIZER, MODEL AMS-1010
2
Cleared 510(K)
K
88
3159
OHMEDA 7800 ANESTHESIA VENTILATOR
2
Cleared 510(K)
K
88
4520
SERVO VENTILATOR 900E
2
Cleared 510(K)
K
88
2764
BEAR EVC-100 CONTROLLER
2
Cleared 510(K)
K
88
0923
PATIENT VENTILATOR ISOLATOR
2
Cleared 510(K)
K
88
1335
BEAR 3 VENTILATOR
2
Cleared 510(K)
K
87
2466
ADULT STAR
2
Cleared 510(K)
K
88
1482
VEOLAR VENTILATOR
2
Cleared 510(K)
K
88
1420
OMNI-VENT, SERIES D/MRI
2
Cleared 510(K)
K
87
3151
MODEL 7200A, PRESSURE VENTILATION OPTION
2
Cleared 510(K)
K
87
1792
VEOLAR VENTILATOR
2
Cleared 510(K)
K
88
0721
6400ST INTERFACE MODULE-RS232
2
Cleared 510(K)
K
88
0054
CPU 1100 VENTILATOR
2
Cleared 510(K)
K
87
2113
OMNI-VENT, SERIES D
2
Cleared 510(K)
K
87
2482
GAMBRO-ENGSTROM ERICA IV RESPIRATOR
2
Cleared 510(K)
K
87
3215
COMPANION 2800A PORTABLE VENTILATOR - MODIFICATION
2
Cleared 510(K)
K
87
0861
UNI-VENT(TM) IMPACT MINUTE VOLUME VENTILATOR
2
Cleared 510(K)
K
87
4415
PRESSURE LIMIT CONTROL
2
Cleared 510(K)
K
87
4371
ASCENDING VENTILATOR BELLOWS
2
Cleared 510(K)
K
87
3549
PEDIATRIC BELLOWS
2
Cleared 510(K)
K
86
3155
UNIVERSAL JET VENTILATOR MODEL AMS-1000
2
Cleared 510(K)
K
87
1354
SERVO VENTILATOR 900 C/D
2
Cleared 510(K)
K
87
1985
BEAR JET VENTILATOR FOR USE DURING (ESWL)
2
Cleared 510(K)
K
87
1433
PPG BIOMEDICAL VENTILATOR MODEL AV 400
2
Cleared 510(K)
K
87
1448
MODEL 105 VENTILATOR
2
Cleared 510(K)
K
87
1398
CPU-1 INTENSIVE CARE VENTILATOR
2
Cleared 510(K)
K
87
1009
MVP-1500 CONTINUOUS VENTILATOR
2
Cleared 510(K)
K
87
0275
COMPANION 2800 PORTABLE VOLUME VENTILATOR
2
Cleared 510(K)
K
86
3228
BIRD 6400ST VOLUME VENTILATOR
2
Cleared 510(K)
K
86
4431
PEDIATRIC BELLOWS
2
Cleared 510(K)
K
86
4129
OHMEDA 7400 ANESTHESIA VENTILATOR
2
Cleared 510(K)
K
86
4379
EMERSON 3MV VOLUME VENTILATOR
2
Cleared 510(K)
K
86
4105
LUNG MECHANICS SOFTWARE PROGRAM
2
Cleared 510(K)
K
86
3546
CPU GRAPH
2
Cleared 510(K)
K
86
2712
EMERSON MODEL 3HV COMPACT VENTILATOR
2
Cleared 510(K)
K
86
2810
COMPANION 2500 PORTABLE VOLUME VENTILATOR
2
Cleared 510(K)
K
86
2604
7200 MICROPROCESS VENT SYS/MODEL 7202 DISPLAY OPT
2
Cleared 510(K)
K
86
0798
ARF-1500 CONTINUOUS VENTILATOR
2
Cleared 510(K)
K
86
2212
LIFECARE REMOTE ALARM #34-001
2
Cleared 510(K)
K
86
1707
MASTER PROGRAM FLOW & PRESSURE CO2 & LUNG MONITOR
2
Cleared 510(K)
K
86
2025
ENGSTROM ERICA II RESPIRATOR
2
Cleared 510(K)
K
86
1432
VEOLAR VENTILATOR
2
Cleared 510(K)
K
86
1488
COMPANION 2800 VOLUME VENTILATOR REMOTE ALARM
2
Cleared 510(K)
K
86
0438
NEWPORT VENTILATOR MODEL E-100
2
Cleared 510(K)
K
86
0675
COMPANION 2800 VOLUME VENTILATOR REMOT ALARM
2
Cleared 510(K)
K
85
3501
HONEYWELL ELECTRONIC VENTILATOR EV-A
2
Cleared 510(K)
K
85
4070
MODIFICATION 7200 MICROPROCESSOR VENTILATOR SYSTEM
2
Cleared 510(K)
K
85
4300
7200 MICROPROCESSOR VENTILATOR SYSTEM RESPIRATORY
2
Cleared 510(K)
K
85
3760
ADULT VENTILATOR TESTER VT-1
2
Cleared 510(K)
K
85
2771
PC INTERFACE
2
Cleared 510(K)
K
85
3300
HEALTHDYNE IMPLUSE VENTILATOR
2
Cleared 510(K)
K
85
1509
OHMEDA 7000 ELECTRONIC ANESTHESIA VENTILATOR
2
Cleared 510(K)
K
85
0374
CONNECTION CABLE FOR SYNCHRONIZATION OF TWO SERVO
2
Cleared 510(K)
K
84
4179
LP-5
2
Cleared 510(K)
K
84
2122
4A
2
Cleared 510(K)
K
84
4081
LP4 VENTILATOR
2
Cleared 510(K)
K
84
4912
SERVO VENTILATOR 900D SIEMENS-ELEMA AB
2
Cleared 510(K)
K
84
4350
NEWPORT VENTILATOR MODEL E-100
2
Cleared 510(K)
K
84
4590
POWER PACK 160 SIEMENS-ELEMA AB
2
Cleared 510(K)
K
84
3424
MICROPROCESSOR 7200A VENTILATOR
2
Cleared 510(K)
K
84
3737
PNEUPAC INSTANT ACTION VENTILATOR/RESUS
2
Cleared 510(K)
K
84
2876
PORTABLE LIFECARE VENTILATOR PLV-102
2
Cleared 510(K)
K
84
2688
BEAR JET-150 VENTILATOR
2
Cleared 510(K)
K
84
2362
PENLON TRANSPORT VENTILATOR SERIES 350
2
Cleared 510(K)
K
84
2363
PENLON ANESTHESIA VENTILATOR SERIES 300
2
Cleared 510(K)
K
84
1818
IMPULSE VENTILATOR
2
Cleared 510(K)
K
84
1529
SIEMENS-ELEMA VENTILATOR 900C
2
Cleared 510(K)
K
84
1279
BEAR 33
2
Cleared 510(K)
K
84
1393
AB MANUAL VENTILATION ACCESS. 900C
2
Cleared 510(K)
K
84
1757
7200 MICROPROCESSOR VENTILATOR
2
Cleared 510(K)
K
84
0865
INFANT STAR VENTILATOR
2
Cleared 510(K)
K
84
0119
CONTINUOUS VENTILATOR
2
Cleared 510(K)
K
83
3982
MODEL IV 100B-DA INFANT VENTILATOR
2
Cleared 510(K)
K
84
0345
IMPULSE VENTILATOR
2
Cleared 510(K)
K
83
2508
VOLUME VENTILATOR
2
Cleared 510(K)
K
83
3786
MICROPROCESSOR VENTILATOR 7200
2
Cleared 510(K)
K
83
2700
PNEU PAC VENTILATOR/RESUSCITATORS
2
Cleared 510(K)
K
83
1877
ARF 850 E
2
Cleared 510(K)
K
83
2467
PORTABLE LIFECARE VENTILATOR PLV-100
2
Cleared 510(K)
K
82
2835
PZ-800 VOLUME VENTILATOR
2
Cleared 510(K)
K
83
0488
VENTILATOR #1
2
Cleared 510(K)
K
83
0230
PROGRAMMABLE VENTILATOR
2
Cleared 510(K)
K
82
3861
ET-3 EMERGENCY TRANSPORT VENTILATOR
2
Cleared 510(K)
K
82
3858
VOLUME VENTILATOR
2
Cleared 510(K)
K
82
2888
OHIO CPU-1 INTENSIVE CARE VENTILATOR
2
Cleared 510(K)
K
82
2635
225 S.I.M.V. VENTILATOR
2
Cleared 510(K)
K
82
2456
OHIO V5A ANESTHESIA VENTILATOR
2
Cleared 510(K)
K
82
2113
INSPIRAID VA-1 VENTILATOR
2
Cleared 510(K)
K
82
2233
ABT 4000 VENTILATOR
2
Cleared 510(K)
K
82
2040
POWERED EMERGENCY VENTILATOR
2
Cleared 510(K)
K
82
1930
SECHRIST MODEL 990 JET VENTILATOR
2
Cleared 510(K)
K
82
1792
NEUMOVENT 980
2
Cleared 510(K)
K
82
2103
MODEL M3000XA VENTILATOR SPECIFICA
2
Cleared 510(K)
K
82
1376
OHIO 7000 ELECTRONIC ANESTHESIA VENTIL.
2
Cleared 510(K)
K
82
0746
NEWPORT VENTILATOR MODEL E100
2
Cleared 510(K)
K
82
0248
RODDER VOLUME VENTILATOR
2
Cleared 510(K)
K
81
2961
SHEFFIELD INFANT VENTILATOR MARK 4
2
Cleared 510(K)
K
82
0393
ANESTHESIA VENTILATOR
2
Cleared 510(K)
K
82
0220
VENTILATOR MODELS
2
Cleared 510(K)
K
81
3254
JET VENTILATOR
2
Cleared 510(K)
K
82
0132
BABYBIRD 2 VENTILATOR
2
Cleared 510(K)
K
81
2958
EAST-FREEMAN VENTILATOR MARK 2
2
Cleared 510(K)
K
81
2016
VS600 JET VENTILATOR
2
Cleared 510(K)
K
81
3253
IC-5 VENTILATOR
2
Cleared 510(K)
K
81
2953
RADCLIFFE VENTILATOR MARK 5
2
Cleared 510(K)
K
81
2980
MA-2 VENTILATOR
2
Cleared 510(K)
K
81
2642
ENGSTROM ERICA
2
Cleared 510(K)
K
81
0893
HEWLETT-PACKARD VENTILATOR
2
Cleared 510(K)
K
81
1141
SECHRIST INFANT VENTRILATOR MODEL IV-100
2
Cleared 510(K)
K
81
1102
SIEMENS-ELEMA AB SERVO VENTILATOR 900 C
2
Cleared 510(K)
K
80
2168
DRAGER AV2 ANESTHESIA VENTILATOR
2
Cleared 510(K)
K
80
2583
INFANT VENTILATOR, (RESPIRATOR) PLAN B
2
Cleared 510(K)
K
80
1890
IC-2 VENTILATOR
2
Cleared 510(K)
K
80
2270
PROTECTIVE BAR FOR THE MA-1VENTILATOR
2
Cleared 510(K)
K
80
2118
BEAR 2 ADULT VOL. VENTILATOR
2
Cleared 510(K)
K
80
2087
BABYBIRD 2 VENTILATOR
2
Cleared 510(K)
K
80
2051
NEWBOURNS INFANT VENTILATOR
2
Cleared 510(K)
K
80
1697
MODEL BP-200 INFANT PRESSURE VENTILATOR
2
Cleared 510(K)
K
80
0999
CAM-10 EXSUFFLATION BELT #11-001
2
Cleared 510(K)
K
80
0650
MOD. 300 ANESTH. VOL. VENTILATOR W/ALARM
2
Cleared 510(K)
K
80
0114
SIEMENS-ELEMA AB MANUAL VENTILATION
2
Cleared 510(K)
K
79
2456
PNEUPAC VENTILATOR/RESUSCITATOR #3
2
Cleared 510(K)
K
79
2455
PNEUPAC VENTILATOR/RESUSCITATOR #2
2
Cleared 510(K)
K
79
2459
PNEUPAC VENTILATOR/RESUSCITATOR
2
Cleared 510(K)
K
80
0125
VENTILATOR TEST LUNG
2
Cleared 510(K)
K
79
2564
MA-1 VENTILATOR & TIMETER AIRCOMPRESSOR
2
Cleared 510(K)
K
79
1713
VICKERS MEDICAL MODEL 130 NEAVENT-NEO
2
Cleared 510(K)
K
79
1186
MODEL BP-2000 TIME-CYCLED VENTILATOR
2
Cleared 510(K)
K
79
1188
CAM-10 BATTERY PACK (#7-001)
2
Cleared 510(K)
K
79
1033
CAM-10 PVV PORTABLE VOLUME VENTILATOR
2
Cleared 510(K)
K
79
0605
RESPIRAOTR, CAM-10 RBL
2
Cleared 510(K)
K
79
0809
VS, ANESTHESIA VENTILATOR
2
Cleared 510(K)
K
79
0733
VENTIMETER VENTILATOR
2
Cleared 510(K)
K
79
0732
VENTIMETER CONTROLLER
2
Cleared 510(K)
K
79
0199
VENTILATOR MODEL BV-300 INFANT
2
Cleared 510(K)
K
78
2074
VENTILATOR, MODEL AVA-1, ADULT
2
Cleared 510(K)
K
78
1926
VENTILATOR, INFANT MODEL 100
2
Cleared 510(K)
K
78
1160
VENTILATOR, MINILUNG
2
Cleared 510(K)
K
78
1159
VENTILATOR, PRESSURE
2
Cleared 510(K)
K
78
1161
RESPIRATOR, BANTAM MODEL
2
Cleared 510(K)
K
78
0188
INFANT VENTILATOR MODEL 100
2
Cleared 510(K)
K
77
2065
CRITICAL CARE VENTILATOR 2
2
Cleared 510(K)
K
77
1039
RESPIRATOR, PROTABLE, VOLUME CONTROLLED
2
Cleared 510(K)
K
77
0132
MODEL LP-3 PORTABLE VOLUME VENTILATOR
2
Cleared 510(K)
K
76
0663
MVP-10 PEDIATRIC/NEONATAL VENTILATOR
2
Cleared 510(K)
CBL
Absorbent, Carbon-Dioxide
1
Product Code
CBN
Apparatus, Gas-Scavenging
2
Product Code
CBO
Attachment, Intermittent Mandatory Ventilation (Imv)
2
Product Code
CBP
Valve, Non-Rebreathing
2
Product Code
MOD
Accessory To Continuous Ventilator (Respirator)
2
Product Code
CCO
Bed, Rocking, Breathing Assist
2
Product Code
CCQ
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
1
Product Code
CCT
Applicator (Laryngo-Tracheal), Topical Anesthesia
2
Product Code
CCW
Laryngoscope, Rigid
1
Product Code
EPE
Brush, Cleaning, Tracheal Tube
1
Product Code
FNC
Tent, Pediatric Aerosol
2
Product Code
FOG
Hood, Oxygen, Infant
1
Product Code
JAY
Support, Breathing Tube
1
Product Code
JOH
Tube Tracheostomy And Tube Cuff
2
Product Code
KFZ
Humidifier, Non-Direct Patient Interface (Home-Use)
1
Product Code
KGB
Mask, Oxygen, Non-Rebreathing
1
Product Code
KHA
Mask, Scavenging
1
Product Code
LNZ
Changer, Tube, Endotracheal
2
Product Code
MIA
Needle, Spinal, Short Term
2
Product Code
MNS
Ventilator, Continuous, Non-Life-Supporting
2
Product Code
MNT
Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
2
Product Code
MRN
Apparatus, Nitric Oxide Delivery
2
Product Code
MRO
Apparatus, Nitric Oxide, Backup Delivery
2
Product Code
MZT
Device, Heimlich Maneuver Assist
2
Product Code
NFB
Conserver, Oxygen
2
Product Code
NHJ
Device, Positive Pressure Breathing, Intermittent
2
Product Code
NHK
Resuscitator, Manual, Non Self-Inflating
2
Product Code
NMA
Tube, Tracheal, Reprocessed
2
Product Code
NMC
Mask, Ventilator, Non-Continuous, Reprocessed
2
Product Code
NMR
Needle, Spinal, Short Term, Reprocessed
2
Product Code
NNH
Needle, Conduction, Anesthesia, Reprocessed
2
Product Code
NOU
Continuous, Ventilator, Home Use
2
Product Code
NQY
Ventilator, Continuous, Minimal Ventilatory Support, Home Use
2
Product Code
NVO
Spacer, Direct Patient Interface
2
Product Code
NVP
Holding Chambers, Direct Patient Interface
2
Product Code
NXA
Tracheotomy Care Kit
2
Product Code
OBN
Humidifier, Respiratory, Mask (Direct Patient Interface)
2
Product Code
OFQ
Anesthesia Kit
2
Product Code
OFT
Spinal Epidural Anesthesia Kit
2
Product Code
OFU
Spinal Anesthesia Kit
2
Product Code
OFV
Regional Anesthesia Kit
2
Product Code
OGA
Brachial Plexus Anesthesia Kit
2
Product Code
OGB
Caudal Anesthesia Kit
2
Product Code
OGC
Continuous Brachial Plexus Block Tray
2
Product Code
OGD
Custom Anesthesia Tray
2
Product Code
OGE
Epidural Anesthesia Kit
2
Product Code
OGF
Glossopharyngeal Anesthesia Kit
2
Product Code
OGG
Humidifier Nebulizer Kit
2
Product Code
OGH
Laryngoscope Kit
1
Product Code
OGI
Nasal Endotracheal Tube Holder Kit
1
Product Code
OGJ
Nerve Block Tray
2
Product Code
OGL
Oxygen Administration Kit
2
Product Code
OLF
Medevac Use Oxygen Generator
2
Product Code
ONZ
Mechanical Ventilator
2
Product Code
OQU
Airway Monitoring System
2
Product Code
PHS
Oral Airway Assist
1
Product Code
PMB
External Airway
2
Product Code
QAV
High Flow/High Velocity Humidified Oxygen Delivery Device
2
Product Code
QBY
Positive Airway Pressure System
2
Product Code
QCX
Retrograde Intubation Set
2
Product Code
OZR
Intraoral Pressure Gradient Device
2
Product Code
QFB
Isocapnic Ventilation Device
2
Product Code
Subpart G—Miscellaneous
CFR Sub-Part
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 16 August 2024 at 11:05 pm
AN
/
subpart-f—therapeutic-devices
/
CBK
/
K061094
View Source
NEWPORT E500 WAVE VENTILATOR
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K061094
510(k) Type
Special
Applicant
NEWPORT MEDICAL INSTRUMENTS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/28/2006
Days to Decision
100 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
Subpart B—Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart C—Monitoring Devices
Subpart D—Prosthetic Devices
Subpart E—Surgical Devices
Subpart F—Cardiovascular Therapeutic Devices
Subpart F—Neurological Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
BRW
Protector, Dental
BSF
Absorber, Carbon-Dioxide
BSJ
Mask, Gas, Anesthetic
BSK
Cuff, Tracheal Tube, Inflatable
BSN
Filter, Conduction, Anesthetic
BSO
Catheter, Conduction, Anesthetic
BSP
Needle, Conduction, Anesthetic (W/Wo Introducer)
BSR
Stylet, Tracheal Tube
BSZ
Gas-Machine, Anesthesia
BTB
Hook, Ether
BTC
Bag, Reservoir
BTK
Strap, Head, Gas Mask
BTL
Ventilator, Emergency, Powered (Resuscitator)
BTM
Ventilator, Emergency, Manual (Resuscitator)
BTO
Tube, Tracheostomy (W/Wo Connector)
BTP
Dropper, Ether
BTQ
Airway, Nasopharyngeal
BTR
Tube, Tracheal (W/Wo Connector)
BTS
Tube, Bronchial (W/Wo Connector)
BTT
Humidifier, Respiratory Gas, (Direct Patient Interface)
BWB
Forceps, Tube Introduction
BWC
Needle, Emergency Airway
BWF
Spirometer, Therapeutic (Incentive)
BWL
Apparatus, Electronanesthesia
BYD
Condenser, Heat And Moisture (Artificial Nose)
BYE
Attachment, Breathing, Positive End Expiratory Pressure
BYF
Mask, Oxygen, Low Concentration, Venturi
BYG
Mask, Oxygen
BYH
Drain, Tee (Water Trap)
BYI
Percussor, Powered-Electric
BYJ
Unit, Liquid-Oxygen, Portable
BYK
Tent, Oxygen, Electrically Powered
BYL
Tent, Oxygen
BYN
Chair, Posture, For Cardiac And Pulmonary Treatment
BYO
Bottle, Blow
BYP
Mouthpiece, Breathing
BYT
Ventilator, External Body, Negative Pressure, Adult (Cuirass)
BYW
Device, Rebreathing
BYX
Tubing, Pressure And Accessories
BZA
Connector, Airway (Extension)
BZB
Catheter, Nasal, Oxygen
BZD
Ventilator, Non-Continuous (Respirator)
BZE
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
BZO
Set, Tubing And Support, Ventilator (W Harness)
BZR
Mixer, Breathing Gases, Anesthesia Inhalation
CAD
Vaporizer, Anesthesia, Non-Heated
CAE
Airway, Oropharyngeal, Anesthesiology
CAF
Nebulizer (Direct Patient Interface)
CAG
Circulator, Breathing-Circuit
CAI
Circuit, Breathing (W Connector, Adaptor, Y Piece)
CAL
Laryngoscope, Non-Rigid
CAO
Airway, Esophageal (Obturator)
CAT
Cannula, Nasal, Oxygen
CAW
Generator, Oxygen, Portable
CAZ
Anesthesia Conduction Kit
CBF
Chamber, Hyperbaric
CBG
Spreader, Cuff
CBH
Device, Fixation, Tracheal Tube
CBI
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
CBK
Ventilator, Continuous, Facility Use
K
24
1520
Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask; Veraseal 3 Full Face Non-Vented Mask; Veraseal 3 Full Face AAV Non-Vented Mask
K
23
2365
Vivo 45 LS
K
23
1778
Nihon Kohden NKV-550 Series Ventilator System
K
21
3098
Panther 5
K
22
0107
Mindray SV600 Ventilator, Mindray SV800 Ventilator
K
22
2644
Nihon Kohden NKV-440 Ventilator System
K
22
2207
Babylog VN800, Babylog VN600
K
22
2024
Evita V800, Evita V600
K
20
1082
LTV2 Series Ventilators
K
21
0384
CARESCAPE R860
K
20
1874
Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1
K
20
3449
F&P Visairo NIV Mask Range
K
20
1306
HAMILTON-C3
K
20
2970
Ventway Sparrow
K
20
1658
Hamilton-C6
K
19
3056
Puritan Bennett 980 Series Ventilator System
K
19
2604
Servo-air 4.0 Ventilator System
K
19
3228
Hamilton-G5
K
19
2307
Nihon Kohden NKV-550 Series Ventilator System
K
18
3364
Bellavista
K
18
1216
HAMILTON-T1, HAMILTON-C1
K
18
0295
Hamilton-G5
K
19
0533
Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Vented Mask, Veraseal 3 Full Face AAV Non-Vented
K
18
1170
Trilogy Evo Universal
K
18
1166
Trilogy Evo
K
18
0098
SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1
K
18
0779
Savina 300
K
18
1695
Nihon Kohden NKV-550 Series Ventilator System
K
17
3973
TV-100
K
17
2875
Astral 100/150
K
17
3060
F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version
K
16
2738
Puritan Bennett 980 Ventilator System
K
17
0037
Breathe Technologies Life2000™ Ventilation System
K
16
2832
731 Series Ventilators
K
16
3127
bellavista 1000
K
16
1450
HAMILTON-C3
K
16
2877
VOCSN Unified Respiratory System
K
15
3046
HAMILTON-MR1
K
15
2068
Astral 100/150
K
14
3035
Flight 60 Ventilator
K
15
1252
Puritan Bennett 840 Series Ventilator System
K
15
1814
SERVO-U Ventilator System, SERVO-n Ventilator System
K
15
1901
AirView
K
15
0638
AF541 SE Full Face Mask
K
14
0939
HAMILTON-T1,HAMILTON-C1
K
14
2679
CARESCAPE R860
K
14
1943
BREATHE TECHNOLOGIES LIFE2000 VENTILATION SYSTEM
K
14
0575
ENGSTROM CARESTATION, ENGSTROM PRO
K
12
1886
SAVINA 300 SAVINA 300, COUNTRY VARIANTS
K
12
3149
SERVO-I VENTILATOR SYSTEM
K
13
3868
ASTRAL VENTILATOR
K
13
0171
FLIGHT 60 VENTILATOR
K
13
1252
PURITAN BENNETT 980 SERIES VENTILATOR SYSTEM
K
12
2438
HAMILTON-MR1
K
13
0178
INSPIRATION VENTILATOR SYSTEM 5I/7I
K
13
1774
HAMILTON-G5
K
12
0931
CRITICAL CARE VENTILATOR
K
12
2560
VERSALVENT MODEL V1 HYPERBARIC CHAMBER VENTILATOR MODEL V1
K
12
3637
HAMILTON-C3
K
11
3743
EVOLUTION 3E VENTILATOR
K
12
0146
QUARK SERIES
K
12
1225
HAMILTON-C2
K
12
1891
NEWPORT AURA VENTILATOR
K
12
1379
PNEUTON MINI VENTILATOR PNEUTON MINI NON-INVASIVE VENTILATION (NIV) KIT ACCESSORY
K
12
0639
PERFORMAX PEDIATRIC SE TOTAL FACE MASK
K
12
0726
FLIGHT 60 VENTILATOR
K
11
2754
IVENT101
K
11
2729
BLEASE700/900 SERIES VENTILATORS
K
12
0574
HAMILTON-C1
K
12
0670
HAMILTON-T1
K
11
3051
SPACELABS ARKON ANESTHESIA WORKSTATION
K
11
1473
UNI-VENT (R) MODEL 731 SERIES PORTABLE CRITICAL CARE VENTILATOR
K
11
2006
HAMILTON-TC1
K
11
1595
NEUMOVENT GRAPHNET
K
11
0083
V200 VENTILATOR WITH APRV MODE, ESPRIT VENTILATOR WITH APRV MODE
K
11
1146
NEWPORT HT70 VENTILATOR
K
10
3803
HAMILTON-G5
K
11
1683
FLIGHT 60 VENTILATOR
K
11
1610
TRILOGY SERIES VENTILATOR WITH OXIMETRY
K
10
3625
OXYLOG 3000 PLUS WORKSTATION, OXYLOG 3000 PLUS BASIC DEVICE
K
11
1116
ENGSTROM CARESTATION, ENGSTROM PRO, MODELS 1505-9000-000, 1505-9003-000
K
11
0795
V200 INTELLI-TRAK OPTION
K
10
2120
NIPPV SILICONE FACE MASK, NIPPV ECONOMY FACE MASK, NIPPV SILICONE NASAL MASK MODEL 10212, 10222, 10202
K
10
3211
AVEA VENTILATOR
K
10
3318
UNI-VENT 731 SERIES MODEL EMV+ PORTABLE CRITICAL CARE VENTILATOR
K
10
1850
SPACELABS BLEASESIRIUS ANESTHESIA WORKSTATION
K
10
1643
MODEL LTV 1100 VENTILATOR
K
10
2775
HAMILTON-C2
K
10
2054
V200 VENTILATOR
K
10
1401
NEUMOVENT GRAPHNET MODEL 3179L1V
K
10
1129
ESPRIT VENTILATOR WITH AF531 SE FULL FACE MASK
K
10
1803
NEWPORT E360 VENTILATOR
K
10
0753
FLIGHT 60 VENTILATOR, MODEL F-60
K
09
3905
TRILOGY 202 VENTILATOR
K
09
3094
VELA VENTILATOR
K
09
3886
ENGSTROM CARESTATION, ENGSTROM PRO
K
09
3632
INFINITY ACUTE CARE SYSTEM WORKSTATION NEONATAL CARE
K
09
3633
INFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CARE
K
09
2847
840 VENTILATOR SYSTEM WITH EXPANDED NEOMODE OPTION
K
09
2148
HAMILTON-C2
K
09
3416
TRILOGY 200 VENTILATOR
K
09
2263
ENDURAVENT-5 VENTILATOR
K
09
2648
RESPIRONICS PERFORMAX SE TOTAL FACE MASK
K
09
2264
ATLANTIS HYPERBARIC CHAMBER VENTILATOR
K
09
2135
MODIFICATION TO IVENT 101
K
09
0888
NEWPORT HT70 FAMILY OF VENTILATORS
K
09
1238
UNI-VENT-731 SERIES VENTILATORS, MODEL 731EMV+
K
09
0468
HAMILTON-C2
K
08
3693
PB 840 VENTILATOR SYSTEM WITH LEAK COMPENSATION OPTION, MODEL 840
K
08
3688
PULMONETIC SYSTEMS LTV 1200 MR CONDITIONAL VENTILATOR
K
08
1845
IVENT101
K
08
3526
TRILOGY 100 VENTILATOR
K
08
3122
HOSPITAL FULL FACE MASK NON VENTED, MODEL: RT041
K
08
2351
NEPTUNE HYPERBARIC VENTILATOR
K
08
3050
EVITE XL
K
08
2724
NEWPORT HTS50 VENTILATOR WITH DUAL PAC BATTERY SYSTEM
K
07
1526
UNI-VENT 731 SERIES VENTILATORS, MODEL 731, 731EMV
K
08
2600
OXYLOG 2000 PLUS SYSTEM (MODEL 5705080), OXYLOG 2000 PLUS BASIC DEVICE (MODEL 5705082)
K
08
2966
PB 540 VENTILATOR
K
07
2926
HELONTIX VENT
K
08
1670
THE ADVANTAGE SERIES NON-VENTED (NV) FULL FACE MASK
K
08
1842
ENGSTROM CARESTATION, ENGSTROM PRO
K
08
1521
MODIFICATION TO HAMILTON-G5
K
08
1743
CLASSICSTAR NV SE AND NOVASTAR NV SE AND AAV FULL FACE MASKS
K
08
1837
AVEA VENTILATOR
K
08
0181
MODIFICATION TO GALILEO GOLD
K
07
3179
SERVO-I VENTILATOR SYSTEM MODEL 64 87 800 E4073, HELIOX OPTION, MODEL 6675585
K
07
3694
IVENT 2001 MRI CONDITIONAL
K
07
2885
CARINA SYSTEM, MODEL 8419350; CARINA BASIC DEVICE, MODEL 5704110
K
07
2412
OPTION SMARTCARE FOR EVITAXL,SMARTCARE KIT CAPNO PACKAGE, CO2 SENSOR CAPNOSMART, MODELS 8415941, 8415942, 6871500
K
07
3069
MODIFICATION TO AVEA VENTILATOR
K
07
2590
INSPIRATION; VENTILATOR SYSTEM, LS VENTILATOR SYSTEM, INFANT VENTILATOR SYSTEM AND INFANT LS VENTILATOR SYSTEM
K
07
2588
PERFORMAX SE TOTAL FACE MASK
K
07
0899
PURITAN BENNETT LEGENDAIR XL2
K
07
2450
ESPRIT VENTILATOR AUTO-TRAK SENSITIVITY OPTION, MODEL V1000
K
07
0513
HAMILTON-G5
K
07
1194
RAPHAEL COLOR ASV VENTILATOR
K
07
0594
PALMTOP VENTILATOR, MODELS PTV-8, PTV-10
K
07
1212
ESPRIT VENTILATOR SPEAKING MODE OPTION, MODEL V1000
K
06
3806
SLEEPNET MOJO -NV FULL FACE MASK, NON-VENTED
K
06
3650
VENTILATOR WITH RESPIRATORY MECHANICS, MODEL 840
K
06
3404
SERVO-I VENTILATOR SYSTEM, MODELS 64, 87 AND 800
K
06
2793
SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E; NAVA OPTION
K
06
2710
GE DATEX-OHMEDA ENGSTROM CARESTATION
K
06
2267
OXYLOG 3000
K
06
2093
AVEA VENTILATOR
K
06
2019
RESPCARE HYBRID NE FACE MASK, MODEL TBD,; DISPOSABLE, MODEL TBD
K
06
1094
NEWPORT E500 WAVE VENTILATOR
K
06
1090
GALILEO GOLD ASV
K
06
1627
MODIFICATION TO I VENT 201
K
06
0705
CARINA HOME
K
06
0862
GE DATEX-OHMEDA ENGSTROM CARESTATION
K
06
0647
LTV 1200 VENTILATOR
K
06
0549
AUTOMOBILE LIGHTER POWER CORD
K
05
3388
MODEL 840 VENTILATOR WITH PROPORTIONAL ASSIST VENTILATION PLUS SOFTWARE OPTION
K
05
3270
IVENT 201
K
05
3502
NEWPORT E360 VENTILATOR
K
05
2863
RAPHAEL COLOR
K
05
1895
GE DATEX-OHMEDA ENGSTROM CARESTATION
K
05
2554
MODIFICATION TO: IVENT 201 PORTABLE VENTILATOR
K
05
1222
AV-S ANAESTHESIA VENTILATOR
K
05
1767
LTV 1000 VENTILATOR
K
05
1550
INSPIRATION VENTILATOR SYSTEM
K
05
1263
EVITAXL WITH OPTION SMARTCARE
K
05
1262
ESPRIT VENTILATOR NEONATAL OPTION, MODEL V1000
K
05
0860
GE DATEX-OHMEDA CENTIVA/5 VENTILATOR
K
05
0597
GE DATEX-OHMEDA ENGSTROM CARESTATION
K
04
3085
MODIFICATION TO: PNEUTON VENTILATOR
K
04
2468
IVENT 201 PORTABLE VENTILATOR
K
04
0574
GALILEO GOLD
K
04
1775
GE DATEX-OHMEDA ENGSTROM CARESTATION
K
03
2922
CLARISSA INFANT NCPAP CANNULA
K
04
1524
GE DATEX-OHMEDA HELIOX DELIVERY SYSTEM
K
04
1223
MODIFICATION TO SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E
K
04
1412
ESPRIT VENTILATOR WITH NICO-ESPRIT INTERFACE OPTION, MODEL V1000
K
04
0790
MODIFICATION TO LTV 1000 VENTILATOR/BREATHING CIRCUITS
K
04
0642
LPO OPTION FOR DRAGER INTENSIVE CARE VENTILATOR SAVINA
K
04
0540
MODIFICATION TO LTV 1000 VENTILATOR
K
03
2451
BIRD TBIRD VELA VENTILATOR
K
04
0221
SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E
K
03
0780
NEWPORT E500 WAVE VENTILATOR
K
03
4040
ESPRIT VENTILATOR, MODEL V1000
K
03
0341
MODIFICATION TO INSPIRATION VENTILATOR SYSTEM
K
02
2679
RAPHAEL
K
03
2226
LTV-1000 VENTILATOR
K
02
3366
DATEX-OHMEDA 7900 VENTILATOR ENHANCEMENTS
K
02
4344
PNEUTON VENTILATOR
K
03
0515
HANS RUDOLPH 7500 SERIES REUSABLE ORO-NASAL NIV MASKS
K
02
3289
OPTION NIV, MODEL 8414115, UPGRADE KIT NIV, MODEL 8414072
K
02
3135
IMAGE3 SE DISPOSABLE FULL FACE MASK
K
01
2691
MONSOON CRITICAL CARE JET VENTILATOR AND ACCESSORIES
K
02
1112
INSPIRATION VENTILATOR SYSTEM
K
02
3350
ESPRIT VENTILATOR WITH RESPIRATORY MECHANICS
K
02
2674
BIRD AVEA VENTILATOR
K
02
2132
SERVO VENTILATOR SYSTEM, MODEL 64 87 800 E407E
K
02
1573
PURITAN-BENNETT 840 VENTILATIOR SYSTEM WITH VOLUME VENTILATION PLUS OPTION
K
01
2693
MISTRAL CRITICAL CARE JET VENTILATOR AND ACCESSORIES
K
01
3642
AVEA
K
02
0746
BIRD TBIRD VELA VENTILATOR
K
01
0793
OXYLOG 1000, MODEL 2M86840
K
01
0925
SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E
K
01
2177
VENTVIEW, MODEL 8414095
K
01
0317
AV 800 VENTILATOR
K
01
1957
IVENT 201 PORTABLE VENTILATOR
K
00
3068
SAVINA
K
01
0093
NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 474
K
01
0608
MODIFICATION TO LAP TOP VENTILATOR (LTV)
K
00
3770
BIRD TBIRD LEGACY VENTILATOR
K
00
2951
MAGELLAN VENTILATOR
K
00
1646
PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTION
K
00
2686
ACHIEVA VENTILATOR Y-ACH+E, ACHIEVA PS VENTILATOR Y-ACHPS+E, ACHIEVA PSO2 VENTILATOR Y-ACHPS02+E
K
00
2881
VENTILATOR, CONTINUOUS (RESPIRATOR), MODEL LTV 1000
K
99
2133
NEWPORT HT50 VENTILATOR WITH HUMIDIFIER HT50-H, NEWPORT HT50 VENTILATOR WITHOUT HUMIDIFIER, HT50-H1, NEWPORT HT50 VENTIL
K
00
1686
GALILEO VENTILATOR
K
00
1208
ESPIRT
K
99
3449
BIRD V.I.P. GOLD/STERLING
K
99
3071
PURITAN-BENNETT VENTILATOR SYSTEM WITH ET/TRACHEOSTOMY TUBE COMPENSATION, TC, OPTION, MODEL 840
K
99
0177
NELLCOR PURITAN BENNETT ACHIEVA VENTILATOR AND REPORT GENERATOR
K
99
3167
MILLENNIUM INFANT VENTILATOR
K
97
2833
E100M VENTILATOR (E100M)
K
99
2670
OXYGEN ENRICHMENT KIT, MODELS SG 066, SG 067
K
99
2788
BEAR CUB 750 PSV
K
98
2910
HAMILTON MEDICAL GALILEOVENTILATOR
K
99
2608
ATC OPTION FOR EVITA 2 DURA AND EVITA 4
K
98
2132
BLEASE 6200 ANAESTHESIA VENTILATOR
K
98
4056
LTV 1000
K
98
1668
SMARTVENT 201 PORTABLE VENTILATOR
K
99
0429
MODIFICATION OF VENTURI VENTILATOR
K
98
4577
DRAGER OXYLOG 2000
K
98
4535
PURITAN-BENNETT 840 VENTILATORY SYSTEM WITH BILEVEL OPTION
K
98
4379
NELLCOR PURITAN BENNETT, 760 VENTILATOR SYSTEM
K
98
3219
NEOFLOW OPTION MODEL NUMBERS 8413563, 8411900
K
98
1412
M1145 (UPS1-1.25K-1G-MP) UPS
K
98
3981
BEAR 1000, VEOLAR W LEONARDO GRAPHICS, BICORE CP-2000, BICORE CP-100, HI-LO JET ET TUBE
K
98
1072
ESPRIT VENTILATOR
K
98
1371
LTV 1000 VENTILATOR
K
98
2580
BIRD MONITOR INTERFACE
K
98
0642
EVITA 4 (8411900)
K
98
1971
TBIRD VS/AVS VOLUME VENTILATOR, MODELS 15568, 15570 , LP10 VOLUME VENTILATOR WITH PRESSURE LIMIT MODEL 00-004130, BEAR 3
K
98
0208
DIVAN ANESTHESIA VENTILATOR
K
98
2174
VENTURI VENTILATOR
K
97
4176
BABYLOG 8000 PLUS
K
97
0460
NELLCOR PURITAN BENNETT, 840 VENTILATOR SYSTEM (MODEL 840)
K
97
0158
BABYPAC
K
96
4540
NELLCOR PURITAN BENNETT, 740 VENTILATOR SYSTEM
K
97
2203
BABYBIRD VENTILATOR, PORTABLE LIFECARE VENTILATOR, EXTERNAL PRESSURE LIMITER, VOLUME VENTILATOR WITH PRESSURE LIMIT
K
97
0839
SERVO VENTILATOR 300A
K
97
2248
NELLCOR PURITAN BENNETT GEMINI
K
97
0165
EVITA 2 DURA
K
96
4543
INFRASONICS ADULT VENTILATOR TRENDING OPTION
K
96
1687
EVITA 4
K
95
0853
OPTIONAL DISPLAY AND SOFTWARE FOR DRAGER VENTILATORS
K
96
0168
SIEMENS SERVO SCREEN 390 AND SERVO COMPUTER MODULE 990
K
96
0010
SERVO VENTILATOR 300 COMPUTER INTERFACE
K
96
0964
OHMEDA 7900 ANESTHESIA VENTILATOR
K
95
3238
DRAGER MICRO VENT
K
96
0861
OMICRON MONITOR, DELTA MONITOR
K
95
5865
BEAR CUB INFANT PRESSURE VENTILATOR
K
95
2880
MODEL LP-1000 VOLUME VENTILATOR
K
95
0484
TBIRD VS VENTILATOR AND TBIRD AVS VENTILATOR
K
95
3228
NARKOMED AV2+ ANESTHESIA VENTILATOR
K
94
3106
ADULT VENTILATOR
K
94
3412
VENTURI VENTILATOR
K
94
2938
CROSSVENT-4 VENTILATOR
K
94
3531
OXYLOG 2000
K
94
1308
NEWPORT ELECTRONIC MANOMETER
K
94
1309
NEWPORT ELECTRONIC MANOMETER
K
93
0017
PB 7200 SERIES VENTILATORY SYSTEM W/KEYBOARD
K
92
4043
AUTO-PEEP
K
92
2975
MODEL 7200AE VENTILATOR (ENHANCEMENT)
K
92
2705
MODEL 7200AE VENTILATOR
K
92
2102
PROPORTIONAL SOLENOID VALVE
K
92
6292
BABYLOG 8000 INFANT VENTILATOR
K
93
0747
BIRD 8400TI ADULT VOLUME VENTILATOR
K
92
4930
EVITA
K
93
3262
BIRD AVIAN PORT MILITARY VENT NSN 6530-01-374-8903
K
92
3992
POWER PACK 350/BATTERY PACK 351
K
92
1387
BIRD 8400ST ADULT VOLUME VENTILATOR
K
92
3444
SERVO GRAPHICS
K
92
0113
BIRD GRAPHICS MONITOR
K
92
0121
SECHRIST IV-100B SAVI SYSTEM
K
92
5262
MERIDIAN MEDICAL SYSTEMS VOLUME VENTILATOR CIRCUIT
K
92
2314
VENTILATOR INTERFACE 9291/4
K
92
2654
VENTILATOR ADULT STAR MODIFICATION
K
92
0002
MODEL 7200AE VENTILATOR FLOW BY 2.0 OR OPTION 50
K
92
1821
IBT MODEL SVI
K
91
4607
SEHRIST VOLUME VENTILATOR, MODEL 2200B
K
92
3809
PURITAN-BENNETT MODEL 7200AE VENTILATOR
K
92
3704
INFANT STAR SERIES 500
K
91
5488
PEDIATRIC VENTILATOR AND PARTNER VOLUME MONITOR
K
91
4424
MODEL 6213 REMOTE ALARM
K
92
2477
MODEL 105 VENTILATOR, MODIFICATION
K
91
5312
MODIFICATION PURITAN BENETT COMPANION 2801 VOL VEN
K
91
2619
BEAR 7 VENTILATOR
K
91
1804
INFRASONICS VENTILATOR ADULT STAR, MODIFICATION
K
92
1726
HAYEK OSCILLATOR, MODIFICATION
K
91
3423
LIFECARE REMOTE ALARM II
K
91
3972
STAR SYNC, MODIFICATION
K
90
1448
VEOLAR VENTILATOR
K
91
1336
BIRD NEBULIZATION SYNCHRONIZER
K
91
4485
VENTILATOR STAND
K
91
2533
NARKOMED AV-E VENTILATOR
K
91
1450
INFANT VENTILATOR
K
90
5234
TXP TRANSPORTER FAMILY AND RELATED ACCESSORIES
K
90
3089
BABYLOG 8000 INFANT VENTILATOR
K
91
0847
OHMEDA 7810 ANESTHESIA VENTILATOR
K
90
5235
VDR SINUSOIDAL PERCUSIONATOR FAMILY/RELATE ACCESS
K
90
0744
AMS 3000 PORTABLE JET VENTILATOR
K
90
0745
VS-200S JET VENTILATOR
K
90
2859
SERVO VENTILATOR 300
K
90
2405
MALLARD MEDICAL MODEL 2400 ANESTHESIA VENTILATOR
K
90
5272
ADULT STAR, MODIFICATION
K
90
2506
7200AE MICROPROCESSOR VENTILATOR W/ENHANCED HARD.
K
90
1953
AIROX AXR. 1A
K
89
5513
PERRY SV-1 HYPERBARIC VENTILATOR
K
90
5244
MODEL LP6 VENTILATOR, MODIFICATION
K
90
3010
CONTINUOUS VOLUME VENTILATOR MODEL LP10
K
90
0313
PERCUSSIONAIRE(R) VDR-3 IMV PERCUS/RESPIR 1250 MIN
K
90
0315
PERCUSSIONAIRE TXP TRANSPORTER/RESPIRATORS 750 MIN
K
90
0314
PERCUSSIONAIRE(R) OSCILLATRON-1 PERCUSS 1300 MIN
K
90
2084
OHMEDA 7800 ANESTHESIA VENTILATOR SOFTWARE UPDATE
K
90
1785
NEWPORT WAVE VENTILATOR MODEL E200
K
90
0637
BEAR CEM CONTROLLER
K
90
0465
MAX TRANSPORT VENTILATOR
K
89
6269
SECHRIST VOLUME VENTILATOR MODEL 2200B
K
89
6442
PPG BIOMEDICAL VENTILATOR MODEL IRISA
K
89
7113
PURITAN-BENNETT COMPANION 2801 VOLUME VENTILATOR
K
88
4389
MODIFIED 225/SIMV VOLUME VENTILATOR
K
89
5541
V.I.P. BIRD INFANT - PEDIATRIC VENTILATOR
K
89
6735
TYPE 9290 INTERFACE RESPIRATOR
K
89
6736
TYPE 9291 INTERFACE RESPIRATOR
K
89
6381
MVP-10 MRI INFANT VENTILATOR
K
89
6380
IC-2A MRI ADULT/PEDIATRIC VENTILATOR
K
89
4322
8400ST VOLUME VENTILATOR
K
89
3622
PREEMICARE MODEL 200-II INFANT TRANSPORT VENTIL.
K
89
5779
MODIFIED PERMCATH TRAY (2ND SUBMISSION)
K
89
2886
PERCUSSIONAIRE OSCILLATRON-1 MEDICAL RESPIRATOR
K
89
5486
BIRD (VDR) SINUSOIDAL PERCUSSIONATORS
K
89
4426
LEONARDO INFORMATION SYSTEM
K
89
4316
AMADEUS VENTILATOR
K
89
3786
SERVO ANESTHESIA CIRCLE 985
K
88
4832
PERCUSSIONAIRE RESPIRATORS (MULTIPLE)
K
89
3043
PURITAN-BENNETT 7200SPI MICROPROCESSOR VENTILATOR
K
88
3809
NEWPORT VENTILATOR MODEL E150
K
88
4793
ADVENT VENTILATOR
K
89
0921
DATA EXCHANGE SYSTEM, MODEL 24
K
88
4521
STAR SYNC
K
88
3865
EXTERNAL JET SYNCHRONIZER, MODEL AMS-1010
K
88
3159
OHMEDA 7800 ANESTHESIA VENTILATOR
K
88
4520
SERVO VENTILATOR 900E
K
88
2764
BEAR EVC-100 CONTROLLER
K
88
0923
PATIENT VENTILATOR ISOLATOR
K
88
1335
BEAR 3 VENTILATOR
K
87
2466
ADULT STAR
K
88
1482
VEOLAR VENTILATOR
K
88
1420
OMNI-VENT, SERIES D/MRI
K
87
3151
MODEL 7200A, PRESSURE VENTILATION OPTION
K
87
1792
VEOLAR VENTILATOR
K
88
0721
6400ST INTERFACE MODULE-RS232
K
88
0054
CPU 1100 VENTILATOR
K
87
2113
OMNI-VENT, SERIES D
K
87
2482
GAMBRO-ENGSTROM ERICA IV RESPIRATOR
K
87
3215
COMPANION 2800A PORTABLE VENTILATOR - MODIFICATION
K
87
0861
UNI-VENT(TM) IMPACT MINUTE VOLUME VENTILATOR
K
87
4415
PRESSURE LIMIT CONTROL
K
87
4371
ASCENDING VENTILATOR BELLOWS
K
87
3549
PEDIATRIC BELLOWS
K
86
3155
UNIVERSAL JET VENTILATOR MODEL AMS-1000
K
87
1354
SERVO VENTILATOR 900 C/D
K
87
1985
BEAR JET VENTILATOR FOR USE DURING (ESWL)
K
87
1433
PPG BIOMEDICAL VENTILATOR MODEL AV 400
K
87
1448
MODEL 105 VENTILATOR
K
87
1398
CPU-1 INTENSIVE CARE VENTILATOR
K
87
1009
MVP-1500 CONTINUOUS VENTILATOR
K
87
0275
COMPANION 2800 PORTABLE VOLUME VENTILATOR
K
86
3228
BIRD 6400ST VOLUME VENTILATOR
K
86
4431
PEDIATRIC BELLOWS
K
86
4129
OHMEDA 7400 ANESTHESIA VENTILATOR
K
86
4379
EMERSON 3MV VOLUME VENTILATOR
K
86
4105
LUNG MECHANICS SOFTWARE PROGRAM
K
86
3546
CPU GRAPH
K
86
2712
EMERSON MODEL 3HV COMPACT VENTILATOR
K
86
2810
COMPANION 2500 PORTABLE VOLUME VENTILATOR
K
86
2604
7200 MICROPROCESS VENT SYS/MODEL 7202 DISPLAY OPT
K
86
0798
ARF-1500 CONTINUOUS VENTILATOR
K
86
2212
LIFECARE REMOTE ALARM #34-001
K
86
1707
MASTER PROGRAM FLOW & PRESSURE CO2 & LUNG MONITOR
K
86
2025
ENGSTROM ERICA II RESPIRATOR
K
86
1432
VEOLAR VENTILATOR
K
86
1488
COMPANION 2800 VOLUME VENTILATOR REMOTE ALARM
K
86
0438
NEWPORT VENTILATOR MODEL E-100
K
86
0675
COMPANION 2800 VOLUME VENTILATOR REMOT ALARM
K
85
3501
HONEYWELL ELECTRONIC VENTILATOR EV-A
K
85
4070
MODIFICATION 7200 MICROPROCESSOR VENTILATOR SYSTEM
K
85
4300
7200 MICROPROCESSOR VENTILATOR SYSTEM RESPIRATORY
K
85
3760
ADULT VENTILATOR TESTER VT-1
K
85
2771
PC INTERFACE
K
85
3300
HEALTHDYNE IMPLUSE VENTILATOR
K
85
1509
OHMEDA 7000 ELECTRONIC ANESTHESIA VENTILATOR
K
85
0374
CONNECTION CABLE FOR SYNCHRONIZATION OF TWO SERVO
K
84
4179
LP-5
K
84
2122
4A
K
84
4081
LP4 VENTILATOR
K
84
4912
SERVO VENTILATOR 900D SIEMENS-ELEMA AB
K
84
4350
NEWPORT VENTILATOR MODEL E-100
K
84
4590
POWER PACK 160 SIEMENS-ELEMA AB
K
84
3424
MICROPROCESSOR 7200A VENTILATOR
K
84
3737
PNEUPAC INSTANT ACTION VENTILATOR/RESUS
K
84
2876
PORTABLE LIFECARE VENTILATOR PLV-102
K
84
2688
BEAR JET-150 VENTILATOR
K
84
2362
PENLON TRANSPORT VENTILATOR SERIES 350
K
84
2363
PENLON ANESTHESIA VENTILATOR SERIES 300
K
84
1818
IMPULSE VENTILATOR
K
84
1529
SIEMENS-ELEMA VENTILATOR 900C
K
84
1279
BEAR 33
K
84
1393
AB MANUAL VENTILATION ACCESS. 900C
K
84
1757
7200 MICROPROCESSOR VENTILATOR
K
84
0865
INFANT STAR VENTILATOR
K
84
0119
CONTINUOUS VENTILATOR
K
83
3982
MODEL IV 100B-DA INFANT VENTILATOR
K
84
0345
IMPULSE VENTILATOR
K
83
2508
VOLUME VENTILATOR
K
83
3786
MICROPROCESSOR VENTILATOR 7200
K
83
2700
PNEU PAC VENTILATOR/RESUSCITATORS
K
83
1877
ARF 850 E
K
83
2467
PORTABLE LIFECARE VENTILATOR PLV-100
K
82
2835
PZ-800 VOLUME VENTILATOR
K
83
0488
VENTILATOR #1
K
83
0230
PROGRAMMABLE VENTILATOR
K
82
3861
ET-3 EMERGENCY TRANSPORT VENTILATOR
K
82
3858
VOLUME VENTILATOR
K
82
2888
OHIO CPU-1 INTENSIVE CARE VENTILATOR
K
82
2635
225 S.I.M.V. VENTILATOR
K
82
2456
OHIO V5A ANESTHESIA VENTILATOR
K
82
2113
INSPIRAID VA-1 VENTILATOR
K
82
2233
ABT 4000 VENTILATOR
K
82
2040
POWERED EMERGENCY VENTILATOR
K
82
1930
SECHRIST MODEL 990 JET VENTILATOR
K
82
1792
NEUMOVENT 980
K
82
2103
MODEL M3000XA VENTILATOR SPECIFICA
K
82
1376
OHIO 7000 ELECTRONIC ANESTHESIA VENTIL.
K
82
0746
NEWPORT VENTILATOR MODEL E100
K
82
0248
RODDER VOLUME VENTILATOR
K
81
2961
SHEFFIELD INFANT VENTILATOR MARK 4
K
82
0393
ANESTHESIA VENTILATOR
K
82
0220
VENTILATOR MODELS
K
81
3254
JET VENTILATOR
K
82
0132
BABYBIRD 2 VENTILATOR
K
81
2958
EAST-FREEMAN VENTILATOR MARK 2
K
81
2016
VS600 JET VENTILATOR
K
81
3253
IC-5 VENTILATOR
K
81
2953
RADCLIFFE VENTILATOR MARK 5
K
81
2980
MA-2 VENTILATOR
K
81
2642
ENGSTROM ERICA
K
81
0893
HEWLETT-PACKARD VENTILATOR
K
81
1141
SECHRIST INFANT VENTRILATOR MODEL IV-100
K
81
1102
SIEMENS-ELEMA AB SERVO VENTILATOR 900 C
K
80
2168
DRAGER AV2 ANESTHESIA VENTILATOR
K
80
2583
INFANT VENTILATOR, (RESPIRATOR) PLAN B
K
80
1890
IC-2 VENTILATOR
K
80
2270
PROTECTIVE BAR FOR THE MA-1VENTILATOR
K
80
2118
BEAR 2 ADULT VOL. VENTILATOR
K
80
2087
BABYBIRD 2 VENTILATOR
K
80
2051
NEWBOURNS INFANT VENTILATOR
K
80
1697
MODEL BP-200 INFANT PRESSURE VENTILATOR
K
80
0999
CAM-10 EXSUFFLATION BELT #11-001
K
80
0650
MOD. 300 ANESTH. VOL. VENTILATOR W/ALARM
K
80
0114
SIEMENS-ELEMA AB MANUAL VENTILATION
K
79
2456
PNEUPAC VENTILATOR/RESUSCITATOR #3
K
79
2455
PNEUPAC VENTILATOR/RESUSCITATOR #2
K
79
2459
PNEUPAC VENTILATOR/RESUSCITATOR
K
80
0125
VENTILATOR TEST LUNG
K
79
2564
MA-1 VENTILATOR & TIMETER AIRCOMPRESSOR
K
79
1713
VICKERS MEDICAL MODEL 130 NEAVENT-NEO
K
79
1186
MODEL BP-2000 TIME-CYCLED VENTILATOR
K
79
1188
CAM-10 BATTERY PACK (#7-001)
K
79
1033
CAM-10 PVV PORTABLE VOLUME VENTILATOR
K
79
0605
RESPIRAOTR, CAM-10 RBL
K
79
0809
VS, ANESTHESIA VENTILATOR
K
79
0733
VENTIMETER VENTILATOR
K
79
0732
VENTIMETER CONTROLLER
K
79
0199
VENTILATOR MODEL BV-300 INFANT
K
78
2074
VENTILATOR, MODEL AVA-1, ADULT
K
78
1926
VENTILATOR, INFANT MODEL 100
K
78
1160
VENTILATOR, MINILUNG
K
78
1159
VENTILATOR, PRESSURE
K
78
1161
RESPIRATOR, BANTAM MODEL
K
78
0188
INFANT VENTILATOR MODEL 100
K
77
2065
CRITICAL CARE VENTILATOR 2
K
77
1039
RESPIRATOR, PROTABLE, VOLUME CONTROLLED
K
77
0132
MODEL LP-3 PORTABLE VOLUME VENTILATOR
K
76
0663
MVP-10 PEDIATRIC/NEONATAL VENTILATOR
CBL
Absorbent, Carbon-Dioxide
CBN
Apparatus, Gas-Scavenging
CBO
Attachment, Intermittent Mandatory Ventilation (Imv)
CBP
Valve, Non-Rebreathing
MOD
Accessory To Continuous Ventilator (Respirator)
CCO
Bed, Rocking, Breathing Assist
CCQ
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
CCT
Applicator (Laryngo-Tracheal), Topical Anesthesia
CCW
Laryngoscope, Rigid
EPE
Brush, Cleaning, Tracheal Tube
FNC
Tent, Pediatric Aerosol
FOG
Hood, Oxygen, Infant
JAY
Support, Breathing Tube
JOH
Tube Tracheostomy And Tube Cuff
KFZ
Humidifier, Non-Direct Patient Interface (Home-Use)
KGB
Mask, Oxygen, Non-Rebreathing
KHA
Mask, Scavenging
LNZ
Changer, Tube, Endotracheal
MIA
Needle, Spinal, Short Term
MNS
Ventilator, Continuous, Non-Life-Supporting
MNT
Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
MRN
Apparatus, Nitric Oxide Delivery
MRO
Apparatus, Nitric Oxide, Backup Delivery
MZT
Device, Heimlich Maneuver Assist
NFB
Conserver, Oxygen
NHJ
Device, Positive Pressure Breathing, Intermittent
NHK
Resuscitator, Manual, Non Self-Inflating
NMA
Tube, Tracheal, Reprocessed
NMC
Mask, Ventilator, Non-Continuous, Reprocessed
NMR
Needle, Spinal, Short Term, Reprocessed
NNH
Needle, Conduction, Anesthesia, Reprocessed
NOU
Continuous, Ventilator, Home Use
NQY
Ventilator, Continuous, Minimal Ventilatory Support, Home Use
NVO
Spacer, Direct Patient Interface
NVP
Holding Chambers, Direct Patient Interface
NXA
Tracheotomy Care Kit
OBN
Humidifier, Respiratory, Mask (Direct Patient Interface)
OFQ
Anesthesia Kit
OFT
Spinal Epidural Anesthesia Kit
OFU
Spinal Anesthesia Kit
OFV
Regional Anesthesia Kit
OGA
Brachial Plexus Anesthesia Kit
OGB
Caudal Anesthesia Kit
OGC
Continuous Brachial Plexus Block Tray
OGD
Custom Anesthesia Tray
OGE
Epidural Anesthesia Kit
OGF
Glossopharyngeal Anesthesia Kit
OGG
Humidifier Nebulizer Kit
OGH
Laryngoscope Kit
OGI
Nasal Endotracheal Tube Holder Kit
OGJ
Nerve Block Tray
OGL
Oxygen Administration Kit
OLF
Medevac Use Oxygen Generator
ONZ
Mechanical Ventilator
OQU
Airway Monitoring System
PHS
Oral Airway Assist
PMB
External Airway
QAV
High Flow/High Velocity Humidified Oxygen Delivery Device
QBY
Positive Airway Pressure System
QCX
Retrograde Intubation Set
OZR
Intraoral Pressure Gradient Device
QFB
Isocapnic Ventilation Device
Subpart G—Miscellaneous
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
AN
/
subpart-f—therapeutic-devices
/
CBK
/
K061094
View Source
NEWPORT E500 WAVE VENTILATOR
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K061094
510(k) Type
Special
Applicant
NEWPORT MEDICAL INSTRUMENTS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/28/2006
Days to Decision
100 days
Submission Type
Summary