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
23
3486
731 Series Ventilator
2
Cleared 510(K)
K
22
3120
Ventoux VC2; Ventoux VC3
2
Cleared 510(K)
K
24
1135
RESPOND(R) Ventilator
2
Cleared 510(K)
K
24
1943
Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-Vented Mask
2
Cleared 510(K)
K
23
2836
Family of DIMAR DMAX NIV masks
2
Cleared 510(K)
K
24
0807
VM-2000
2
Cleared 510(K)
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
1166
Trilogy Evo
2
Cleared 510(K)
K
18
1170
Trilogy Evo Universal
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
0745
VS-200S JET VENTILATOR
2
Cleared 510(K)
K
90
0744
AMS 3000 PORTABLE 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
0314
PERCUSSIONAIRE(R) OSCILLATRON-1 PERCUSS 1300 MIN
2
Cleared 510(K)
K
90
0315
PERCUSSIONAIRE TXP TRANSPORTER/RESPIRATORS 750 MIN
2
Cleared 510(K)
K
90
0313
PERCUSSIONAIRE(R) VDR-3 IMV PERCUS/RESPIR 1250 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
6736
TYPE 9291 INTERFACE RESPIRATOR
2
Cleared 510(K)
K
89
6735
TYPE 9290 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
2363
PENLON ANESTHESIA VENTILATOR SERIES 300
2
Cleared 510(K)
K
84
2362
PENLON TRANSPORT VENTILATOR SERIES 350
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
SDS
Compression-Based Airway Clearance Device
2
Product Code
SDT
Intra-Pulmonary Percussive Vibration (Ipv) Devices
2
Product Code
Subpart G—Miscellaneous
CFR Sub-Part
Cardiovascular
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Chemistry
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Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
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General Hospital
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Hematology
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Immunology
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Microbiology
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Neurology
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Obstetrical and Gynecological
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Ophthalmic
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Orthopedic
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Pathology
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Physical Medicine
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Radiology
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General and Plastic Surgery
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Toxicology
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Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 3 January 2025 at 11:05 pm
AN
/
subpart-f—therapeutic-devices
/
CBK
/
K070899
View Source
PURITAN BENNETT LEGENDAIR XL2
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K070899
510(k) Type
Traditional
Applicant
NELLCOR PURITAN BENNETT
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/13/2007
Days to Decision
255 days
Submission Type
Summary