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
K
23
0931
Atlan
2
Cleared 510(K)
K
21
3867
Carestation 750/750c
2
Cleared 510(K)
K
20
1957
A8, A9 Anesthesia System
2
Cleared 510(K)
K
19
1027
Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System
2
Cleared 510(K)
K
17
1292
A7 Anesthesia System
2
Cleared 510(K)
K
17
1311
A5 Anesthesia System
2
Cleared 510(K)
K
17
2045
Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Avance, Avance CS2, Aisys, Aisys CS2
2
Cleared 510(K)
K
17
0872
Aisys CS2
2
Cleared 510(K)
K
16
0665
FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40
2
Cleared 510(K)
K
15
1570
Carestation 620/650/650C
2
Cleared 510(K)
K
15
1954
A7 Anesthesia System
2
Cleared 510(K)
K
14
3530
Aespire View
2
Cleared 510(K)
K
14
2552
A7 Anesthesia System
2
Cleared 510(K)
K
14
0264
MADM
2
Cleared 510(K)
K
13
2903
DRE VENTURA
2
Cleared 510(K)
K
13
3886
PERSEUS A500
2
Cleared 510(K)
K
13
1790
A9800 ANESTHESIA WORKSTATION
2
Cleared 510(K)
K
13
3958
FLOW-I ANESTHESIA SYSTEM C20, C30 & C40
2
Cleared 510(K)
K
13
2530
GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2)
2
Cleared 510(K)
K
13
1945
GE DATEX-OHMEDA AVANCE CS2
2
Cleared 510(K)
K
12
2063
INTELLISAVE AX700 ANESTHESIA SYSTEM
2
Cleared 510(K)
K
12
3211
A5 ANESTHESIA DELIVERY SYSTEM
2
Cleared 510(K)
K
12
3125
GE DATEX-OHMEDA AVANCE CS2
2
Cleared 510(K)
K
12
2445
AESPIRE 7900, AESPIRE VIEW
2
Cleared 510(K)
K
11
3633
MCKESSON ANESTHESIA CARE
2
Cleared 510(K)
K
10
3035
SMARTPILOT VIEW MODEL MK04500
2
Cleared 510(K)
K
12
0075
AM-6000 ANESTHESIA MACHINE
2
Cleared 510(K)
K
11
2114
MAQUET FLOW-I C20, MAQUET FLOW-I C30, MAQUET FLOW-I C40
2
Cleared 510(K)
K
11
2722
GE DATEX-OHMEDA AVANCE
2
Cleared 510(K)
K
11
0213
GE DATEX-OHMEDA AISYS
2
Cleared 510(K)
K
10
2389
NAVIGATOR APPLICATIONS SUITE
2
Cleared 510(K)
K
10
2182
MAQUET FLOW-I C20, MAQUET FLOW-I C30, MODEL 66 77 200, 66 77 30
2
Cleared 510(K)
K
10
2471
AS3700 ANESTHSIA DELIVERY SYSTEM
2
Cleared 510(K)
K
10
1439
CODONICS SAFE LABELING SYSTEM (SLS), MODEL 500I/500P
2
Cleared 510(K)
K
09
2864
AESPIRE 7900, AESPIRE VIEW
2
Cleared 510(K)
K
09
0892
GE DATEX-OHMEDA S/5 ADU CARESTATION
2
Cleared 510(K)
K
08
3098
NAVIGATOR APPLICATIONS SUITE
2
Cleared 510(K)
K
09
0233
GE DATEX-OHMEDA AISYS
2
Cleared 510(K)
K
08
3413
COMPURECORD PERI-OPERATIVE ANESTHESIOLOGY INFORMATION SYSTEM
2
Cleared 510(K)
K
08
1447
FOURTH GAS MODULE WITH CO2 FOR PRIMUS US APOLLO
2
Cleared 510(K)
K
08
1844
GE DATEX-OHMEDA AVANCE
2
Cleared 510(K)
K
08
1941
NAVIGATOR APPLICATIONS SUITE
2
Cleared 510(K)
K
07
2884
FABIUS MRI
2
Cleared 510(K)
K
08
0175
NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 0998-00-3024-01
2
Cleared 510(K)
K
07
3707
GE DATEX-OHMEDA AISYS
2
Cleared 510(K)
K
07
2420
MAGELLAN-2200, MODEL-3 ANESTHESIA MACHINE
2
Cleared 510(K)
K
07
1097
NAVIGATOR APPLICATIONS SUITE
2
Cleared 510(K)
K
07
1142
GE DATEX-OHMEDA AVANCE ANESTHESIA SYSTEM
2
Cleared 510(K)
K
06
2388
ANESTHESIA INFORMATION AND DIGITAL-DRUG MANAGEMENT SYSTEM
2
Cleared 510(K)
K
06
2155
DIGITAL MXR-D FLOWMETER
2
Cleared 510(K)
K
06
1102
PRIMA ANAESTHESIA MACHINE
2
Cleared 510(K)
K
06
1609
GE DATEX-OHMEDA AISYS
2
Cleared 510(K)
K
06
0193
MAGELLAN-2200 MODEL -2 ANESTHESIA MACHINE, MODEL 2
2
Cleared 510(K)
K
05
2335
ANALGESIA GAS MACHINE, MODEL DIGITAL ULTRA
2
Cleared 510(K)
K
05
0883
SAFERSLEEP SYSTEM
2
Cleared 510(K)
K
05
1629
BLEAS ESIRIUC ANAESTHSIA SYSTEM, MODELS 3000, 2000
2
Cleared 510(K)
K
05
0676
GE DETAX-OHMEDA ANESTHESIA DELIVERY UNIT (ADU)
2
Cleared 510(K)
K
05
0626
GE DATEX-OHMEDA AESPIRE 7900 ANESTHESIA SYSTEM
2
Cleared 510(K)
K
05
0055
GE DATEX-OHMEDA AESTIVA/5 MRI ANESTHESIA SYSTEM
2
Cleared 510(K)
K
04
2607
PRIMUS US
2
Cleared 510(K)
K
04
2419
FABIUS GS/FABIUS TIRO ANESTHESIA SYSTEM
2
Cleared 510(K)
K
04
1430
BLEASE SIRIUS ANESTHESIA SYSTEM, MODELS 3000 AND 2000
2
Cleared 510(K)
K
03
3026
MALLARD MODEL 3000 ANESTHESIA MACHINE
2
Cleared 510(K)
K
04
2154
GE DATEX-OHMEDA AISYS CARESTATION
2
Cleared 510(K)
K
04
2086
FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM
2
Cleared 510(K)
K
04
1622
MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM
2
Cleared 510(K)
K
03
3498
NARKOMED 6400, MODEL NM6400
2
Cleared 510(K)
K
04
0743
MODIFICATION TO DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM
2
Cleared 510(K)
K
03
0624
MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM
2
Cleared 510(K)
K
03
2803
DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM
2
Cleared 510(K)
K
03
1400
FABIUS TIRO ANESTHESIA SYSTEM
2
Cleared 510(K)
K
03
0939
PHILIPS COMPURECORD PERI-OPERATIVE INFORMATION SYSTEM SOFTWARE
2
Cleared 510(K)
K
02
2031
NARKOMED MRI-2 ANESTHESIA SYSTEM, MODEL NM-MRI-2
2
Cleared 510(K)
K
01
1404
FABIUS GS ANESTHESIA SYSTEM, MODEL FABIUS GS
2
Cleared 510(K)
K
01
0613
MAGELLAN-2200, MODEL 1
2
Cleared 510(K)
K
01
2446
OFFICE BASED ANESTHESIA MACHINE MRI, MODEL OBA-1 MRI
2
Cleared 510(K)
K
00
3663
SPACELABS MEDICAL ANESTHESIA DELIVERY SYSTEM (ADS) WITH PRESSURE CONTROL MODE
2
Cleared 510(K)
K
00
3251
BLEASE FRONTLINE PLUS RANGE, ANESTHESIA MACHINES, MODEL 440, 560 AND 690
2
Cleared 510(K)
K
00
1988
MODULAR
2
Cleared 510(K)
K
00
3579
NARKOMED MRI-2, MODEL NM-MRI-2
2
Cleared 510(K)
K
00
0995
NARKOMAT, MODEL 2000
2
Cleared 510(K)
K
00
0859
OFFICE BASED ANESTHESIA MACHINE, MODEL OBA-1
2
Cleared 510(K)
K
00
1727
MODIFICATION TO BLEASE FRONTLINE GENIUS RANGE, ANESTHESIA MACHINES
2
Cleared 510(K)
K
00
1488
NARKOMED MRI , NM-MRI
2
Cleared 510(K)
K
00
1315
MODIFICATION TO KION ANESTHESIA SYSTEM
2
Cleared 510(K)
K
00
0706
DATEX-OHMEDA AESTIVA/5 WITH 7100 VENTILATOR
2
Cleared 510(K)
K
99
3410
DATES-OHMEDA AESTIVA SMARTVENT MRI
2
Cleared 510(K)
K
99
2421
GUARDIAN LOW PRESSURE ALARM ACCESSORY, MODEL 34076
2
Cleared 510(K)
K
97
3971
KION ANESTHESIA SYSTEM
2
Cleared 510(K)
K
98
2137
BLEASE FRONTLINE GENIUS RANGE ANAESTHESIA MACHINE
2
Cleared 510(K)
K
98
3635
JULIAN ANESTHESIA WORKSTATION, MODEL # JULIAN
2
Cleared 510(K)
K
98
1530
SPACELABS MEDICAL 90519 ANESTHESIA DELIVERY SYSTEM
2
Cleared 510(K)
K
98
1845
HAWK ANAESTHESIA INDUCTION UNIT
2
Cleared 510(K)
K
97
3985
AS/3 ANAESTHESIA DELIVERY UNIT (AS/3 ADU)
2
Cleared 510(K)
K
98
0553
NARKOMED 6000 MODEL NUMBER NM6000
2
Cleared 510(K)
K
97
3896
OHMEDA EXCEL 3000 ANESTHESIA SYSTEM
2
Cleared 510(K)
K
97
3949
PERIOPERATIVE DATA MANAGEMENT SYSTEM
2
Cleared 510(K)
K
97
4193
NARKOMED ULTRASONIC FLOW SENSOR
2
Cleared 510(K)
K
97
0163
ALPHA MX (20)/ULTRA PC (30)
2
Cleared 510(K)
K
97
1030
MIE FALCON, DATEX ENGSTROM FLEXIMA II
2
Cleared 510(K)
K
97
2848
NARKOMED MRI ANESTHESIA SYSTEM
2
Cleared 510(K)
K
96
5160
HP ORVUE INTRA-OP (M2510A)
2
Cleared 510(K)
K
97
1425
NARKOMED M ANESTHESIA SYSTEM (M)
2
Cleared 510(K)
K
96
3481
ANODYNE CC
2
Cleared 510(K)
K
96
5041
OHMEDA APAC (ADVANCED PORTABLE ANESTHESIA CARE) SYSTEM
2
Cleared 510(K)
K
96
3994
NARKOMED GS ANESTHESIA SYSTEM
2
Cleared 510(K)
K
94
6127
OHMEDA EXCEL DRAW-OVER MILITARY VAPORIZER SYSTEM
2
Cleared 510(K)
K
94
5463
PENDANT MOUNT NARKOMED 2C ANESTHESIUA SYSTEM
2
Cleared 510(K)
K
94
5234
AS/3 MEMORY MODULE, M0MEM
2
Cleared 510(K)
K
94
5722
MATRX MDM, RA
2
Cleared 510(K)
K
93
3285
DATEX AS/3 TM ANAESTHESIA MONITOR
2
Cleared 510(K)
K
92
3172
ANAESTHESIA RECORD KEEPER
2
Cleared 510(K)
K
93
5546
MAC/IV SEDATION KIT
2
Cleared 510(K)
K
93
4669
ARC
2
Cleared 510(K)
K
93
0351
NARKOMED 2C ANESTHESIA SYSTEM
2
Cleared 510(K)
K
93
0492
IDACARE ANESTHESIA MANAGEMENT WORKSTATIN
2
Cleared 510(K)
K
92
5580
OHMEDA TEC 6 (CFV) CONTINUOUS FLOW VAPORIZER, NAD
2
Cleared 510(K)
K
92
1742
OHMEDA AUTOCLAVABLE BELLOWS ASSEMBLY
2
Cleared 510(K)
K
91
3791
OHMEDA 7800 ANESTHESIA VENTILATOR
2
Cleared 510(K)
K
92
3519
SENSOR GUI
2
Cleared 510(K)
K
92
0944
FTS-200 GAS SYSTEM
2
Cleared 510(K)
K
90
5635
OHMEDA MODULUS CD ANESTHESIA SYSTEM
2
Cleared 510(K)
K
90
3991
PCM ANESTHESIA
2
Cleared 510(K)
K
90
3135
CLINI-CALC
2
Cleared 510(K)
K
90
1117
OHMEDA UNIVERSAL PAC
2
Cleared 510(K)
K
90
2962
LIFELOG(TM)
2
Cleared 510(K)
K
90
1713
NARKOMED 4 ANESTHESIA SYSTEM
2
Cleared 510(K)
K
90
1119
OHMEDA MODULUS CD ANESTHESIA SYSTEM
2
Cleared 510(K)
K
89
3780
OHMEDA EXCEL MRI COMPATIBLE ANESTHESIA SYSTEM
2
Cleared 510(K)
K
90
0937
O.R. DATA MANAGER
2
Cleared 510(K)
K
90
0328
NARKOMED 2B ANESTHESIA SYSTEM
2
Cleared 510(K)
K
90
0329
NARKOMED 3 ANESTHESIA SYSTEM
2
Cleared 510(K)
K
89
4309
OHMEDA MODULUS CD ANESTHESIA SYSTEM
2
Cleared 510(K)
K
88
4802
CAVENDISH 460/680 ANESTHESIA MACHINE
2
Cleared 510(K)
K
88
4991
CARDIOCAP CCK-104 KEYBOARD & CCP-104 GRAPHICS PRIN
2
Cleared 510(K)
K
89
0410
REVISED OHMEDA MODULUS II ANESTHESIA GAS MACHINE
2
Cleared 510(K)
K
88
4879
CENTURION(TM) MIXER
2
Cleared 510(K)
K
88
2489
REVISED PNEUMATIC DIAGRAMS FOR MODULUS II PLUS
2
Cleared 510(K)
K
87
5350
OHMEDA MODULUS II PLUS ANESTHESIA SYSTEM
2
Cleared 510(K)
K
87
2178
MODIFICATION TO ARKIVE(TM)
2
Cleared 510(K)
K
86
4589
TRI-SERVICE OMV VAPORIZER
2
Cleared 510(K)
K
86
4590
AM1000
2
Cleared 510(K)
K
86
4644
PHOENIX-C ANESTHESIA MACHINE
2
Cleared 510(K)
K
86
4447
NARKOMED 2B ANESTHESIA SYSTEM
2
Cleared 510(K)
K
86
4806
ANESTHESIA RECORDER
2
Cleared 510(K)
K
86
2085
ARKIVE (TM)
2
Cleared 510(K)
K
86
3207
OHMEDA 'B' SERIES GAS DELIVERY SYSTEM
2
Cleared 510(K)
K
86
2831
MODIFIED OHMEDA PAC PORTABLE ANESTHESIA SYSTEM
2
Cleared 510(K)
K
86
1170
NARKOMED 3 ANESTHESIA SYSTEM (MODIFIED)
2
Cleared 510(K)
K
85
5022
COMPUTERIZED ANESTHESIA RECORDING & INFO NETWORK
2
Cleared 510(K)
K
85
3435
NARKOMED 3 ANESTHESIA SYSTEM
2
Cleared 510(K)
K
85
4213
ARI STANDARD ANESTHESIA RECORD
2
Cleared 510(K)
K
85
2175
PATIENT DATA SYSTEMS CVA
2
Cleared 510(K)
K
85
3139
PHOENIX ANESTHESIA MACHINE
2
Cleared 510(K)
K
85
0648
OHMEDA PAC PORTABLE ANESTHESIA SYSTEM
2
Cleared 510(K)
K
84
4563
PHOENIX ANESTHESIA MACHINE
2
Cleared 510(K)
K
84
4849
OHMEDA MDM ELECTRONIC-GAS MACHINE FOR ANALGESIA
2
Cleared 510(K)
K
85
1621
BOOM ARM
2
Cleared 510(K)
K
84
4008
PENLON AM1000 ANAESTHESIA MACHINE
2
Cleared 510(K)
K
84
4421
FOREGGER DOME VALVES
2
Cleared 510(K)
K
84
4012
OHMEDA ANESTHESIA RECORD KEEPER
2
Cleared 510(K)
K
84
1370
KMA-1300F
2
Cleared 510(K)
K
84
0356
OHIO UNITROL II ANESTHESIA GAS MACHINE
2
Cleared 510(K)
K
84
1274
BAG-TO-VENTILATOR SELECTOR VALVE
2
Cleared 510(K)
K
83
3147
CENTRALERT
2
Cleared 510(K)
K
83
3335
MODULUS II ANESTHESIA GAS MACHINE
2
Cleared 510(K)
K
83
3151
BOYLE SYSTEM ANESTHESIA GAS MACHINE
2
Cleared 510(K)
K
83
0680
AIR-SHIELDS VENTIMETER VENTILATOR-CONTR
2
Cleared 510(K)
K
83
0160
ANESTHESIA APPARATUS #FO 20S
2
Cleared 510(K)
K
83
0161
ANESTHESIA APATATUS #D-25
2
Cleared 510(K)
K
83
0159
ANESTHESIA APPARATUS PH-35
2
Cleared 510(K)
K
82
2218
NARKOMED 2A ANESTHESIA MACHINE
2
Cleared 510(K)
K
80
3052
NUFFIELD ANESTHESIA VENTILATOR SER. 400
2
Cleared 510(K)
K
80
2591
MODEL 5460 + 5480 POP-OFF VALVES
2
Cleared 510(K)
K
80
1102
COMPALOR-ORAL SURGERY MODEL
2
Cleared 510(K)
K
80
1100
ANALOR FOUR-DENTAL MODEL
2
Cleared 510(K)
K
80
1103
COMPALOR-DENTAL MODEL
2
Cleared 510(K)
K
80
0801
ANALGESIA UNITS, OXYGEN & NITRATE DEVICE
2
Cleared 510(K)
K
79
1530
OHIO MODULAR ANESTHESIA GAS MACHINE
2
Cleared 510(K)
K
79
0456
SERIES 7000
2
Cleared 510(K)
K
78
1492
SERIES 7000 GAS MACHINE
2
Cleared 510(K)
K
77
1989
CONTINUOUS FLOW ANESTHESIA MACHINE
2
Cleared 510(K)
K
77
1479
NITROX 30 - ANESTHETIC GAS PROPORTIONER
2
Cleared 510(K)
K
77
1057
ANESTHESIA MACHINE
2
Cleared 510(K)
K
77
0554
NARKOMED ANESTHESIA MACHINE
2
Cleared 510(K)
K
76
0228
ANESTHESIA MACHINE, CHEMETRON
2
Cleared 510(K)
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
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 6 December 2024 at 11:05 pm
AN
/
subpart-f—therapeutic-devices
/
BSZ
/
K001988
View Source
MODULAR
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K001988
510(k) Type
Traditional
Applicant
HEYER AMERICA, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/5/2001
Days to Decision
221 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
K
23
0931
Atlan
K
21
3867
Carestation 750/750c
K
20
1957
A8, A9 Anesthesia System
K
19
1027
Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System
K
17
1292
A7 Anesthesia System
K
17
1311
A5 Anesthesia System
K
17
2045
Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Avance, Avance CS2, Aisys, Aisys CS2
K
17
0872
Aisys CS2
K
16
0665
FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40
K
15
1570
Carestation 620/650/650C
K
15
1954
A7 Anesthesia System
K
14
3530
Aespire View
K
14
2552
A7 Anesthesia System
K
14
0264
MADM
K
13
2903
DRE VENTURA
K
13
3886
PERSEUS A500
K
13
1790
A9800 ANESTHESIA WORKSTATION
K
13
3958
FLOW-I ANESTHESIA SYSTEM C20, C30 & C40
K
13
2530
GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2)
K
13
1945
GE DATEX-OHMEDA AVANCE CS2
K
12
2063
INTELLISAVE AX700 ANESTHESIA SYSTEM
K
12
3211
A5 ANESTHESIA DELIVERY SYSTEM
K
12
3125
GE DATEX-OHMEDA AVANCE CS2
K
12
2445
AESPIRE 7900, AESPIRE VIEW
K
11
3633
MCKESSON ANESTHESIA CARE
K
10
3035
SMARTPILOT VIEW MODEL MK04500
K
12
0075
AM-6000 ANESTHESIA MACHINE
K
11
2114
MAQUET FLOW-I C20, MAQUET FLOW-I C30, MAQUET FLOW-I C40
K
11
2722
GE DATEX-OHMEDA AVANCE
K
11
0213
GE DATEX-OHMEDA AISYS
K
10
2389
NAVIGATOR APPLICATIONS SUITE
K
10
2182
MAQUET FLOW-I C20, MAQUET FLOW-I C30, MODEL 66 77 200, 66 77 30
K
10
2471
AS3700 ANESTHSIA DELIVERY SYSTEM
K
10
1439
CODONICS SAFE LABELING SYSTEM (SLS), MODEL 500I/500P
K
09
2864
AESPIRE 7900, AESPIRE VIEW
K
09
0892
GE DATEX-OHMEDA S/5 ADU CARESTATION
K
08
3098
NAVIGATOR APPLICATIONS SUITE
K
09
0233
GE DATEX-OHMEDA AISYS
K
08
3413
COMPURECORD PERI-OPERATIVE ANESTHESIOLOGY INFORMATION SYSTEM
K
08
1447
FOURTH GAS MODULE WITH CO2 FOR PRIMUS US APOLLO
K
08
1844
GE DATEX-OHMEDA AVANCE
K
08
1941
NAVIGATOR APPLICATIONS SUITE
K
07
2884
FABIUS MRI
K
08
0175
NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 0998-00-3024-01
K
07
3707
GE DATEX-OHMEDA AISYS
K
07
2420
MAGELLAN-2200, MODEL-3 ANESTHESIA MACHINE
K
07
1097
NAVIGATOR APPLICATIONS SUITE
K
07
1142
GE DATEX-OHMEDA AVANCE ANESTHESIA SYSTEM
K
06
2388
ANESTHESIA INFORMATION AND DIGITAL-DRUG MANAGEMENT SYSTEM
K
06
2155
DIGITAL MXR-D FLOWMETER
K
06
1102
PRIMA ANAESTHESIA MACHINE
K
06
1609
GE DATEX-OHMEDA AISYS
K
06
0193
MAGELLAN-2200 MODEL -2 ANESTHESIA MACHINE, MODEL 2
K
05
2335
ANALGESIA GAS MACHINE, MODEL DIGITAL ULTRA
K
05
0883
SAFERSLEEP SYSTEM
K
05
1629
BLEAS ESIRIUC ANAESTHSIA SYSTEM, MODELS 3000, 2000
K
05
0676
GE DETAX-OHMEDA ANESTHESIA DELIVERY UNIT (ADU)
K
05
0626
GE DATEX-OHMEDA AESPIRE 7900 ANESTHESIA SYSTEM
K
05
0055
GE DATEX-OHMEDA AESTIVA/5 MRI ANESTHESIA SYSTEM
K
04
2607
PRIMUS US
K
04
2419
FABIUS GS/FABIUS TIRO ANESTHESIA SYSTEM
K
04
1430
BLEASE SIRIUS ANESTHESIA SYSTEM, MODELS 3000 AND 2000
K
03
3026
MALLARD MODEL 3000 ANESTHESIA MACHINE
K
04
2154
GE DATEX-OHMEDA AISYS CARESTATION
K
04
2086
FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM
K
04
1622
MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM
K
03
3498
NARKOMED 6400, MODEL NM6400
K
04
0743
MODIFICATION TO DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM
K
03
0624
MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM
K
03
2803
DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM
K
03
1400
FABIUS TIRO ANESTHESIA SYSTEM
K
03
0939
PHILIPS COMPURECORD PERI-OPERATIVE INFORMATION SYSTEM SOFTWARE
K
02
2031
NARKOMED MRI-2 ANESTHESIA SYSTEM, MODEL NM-MRI-2
K
01
1404
FABIUS GS ANESTHESIA SYSTEM, MODEL FABIUS GS
K
01
0613
MAGELLAN-2200, MODEL 1
K
01
2446
OFFICE BASED ANESTHESIA MACHINE MRI, MODEL OBA-1 MRI
K
00
3663
SPACELABS MEDICAL ANESTHESIA DELIVERY SYSTEM (ADS) WITH PRESSURE CONTROL MODE
K
00
3251
BLEASE FRONTLINE PLUS RANGE, ANESTHESIA MACHINES, MODEL 440, 560 AND 690
K
00
1988
MODULAR
K
00
3579
NARKOMED MRI-2, MODEL NM-MRI-2
K
00
0995
NARKOMAT, MODEL 2000
K
00
0859
OFFICE BASED ANESTHESIA MACHINE, MODEL OBA-1
K
00
1727
MODIFICATION TO BLEASE FRONTLINE GENIUS RANGE, ANESTHESIA MACHINES
K
00
1488
NARKOMED MRI , NM-MRI
K
00
1315
MODIFICATION TO KION ANESTHESIA SYSTEM
K
00
0706
DATEX-OHMEDA AESTIVA/5 WITH 7100 VENTILATOR
K
99
3410
DATES-OHMEDA AESTIVA SMARTVENT MRI
K
99
2421
GUARDIAN LOW PRESSURE ALARM ACCESSORY, MODEL 34076
K
97
3971
KION ANESTHESIA SYSTEM
K
98
2137
BLEASE FRONTLINE GENIUS RANGE ANAESTHESIA MACHINE
K
98
3635
JULIAN ANESTHESIA WORKSTATION, MODEL # JULIAN
K
98
1530
SPACELABS MEDICAL 90519 ANESTHESIA DELIVERY SYSTEM
K
98
1845
HAWK ANAESTHESIA INDUCTION UNIT
K
97
3985
AS/3 ANAESTHESIA DELIVERY UNIT (AS/3 ADU)
K
98
0553
NARKOMED 6000 MODEL NUMBER NM6000
K
97
3896
OHMEDA EXCEL 3000 ANESTHESIA SYSTEM
K
97
3949
PERIOPERATIVE DATA MANAGEMENT SYSTEM
K
97
4193
NARKOMED ULTRASONIC FLOW SENSOR
K
97
0163
ALPHA MX (20)/ULTRA PC (30)
K
97
1030
MIE FALCON, DATEX ENGSTROM FLEXIMA II
K
97
2848
NARKOMED MRI ANESTHESIA SYSTEM
K
96
5160
HP ORVUE INTRA-OP (M2510A)
K
97
1425
NARKOMED M ANESTHESIA SYSTEM (M)
K
96
3481
ANODYNE CC
K
96
5041
OHMEDA APAC (ADVANCED PORTABLE ANESTHESIA CARE) SYSTEM
K
96
3994
NARKOMED GS ANESTHESIA SYSTEM
K
94
6127
OHMEDA EXCEL DRAW-OVER MILITARY VAPORIZER SYSTEM
K
94
5463
PENDANT MOUNT NARKOMED 2C ANESTHESIUA SYSTEM
K
94
5234
AS/3 MEMORY MODULE, M0MEM
K
94
5722
MATRX MDM, RA
K
93
3285
DATEX AS/3 TM ANAESTHESIA MONITOR
K
92
3172
ANAESTHESIA RECORD KEEPER
K
93
5546
MAC/IV SEDATION KIT
K
93
4669
ARC
K
93
0351
NARKOMED 2C ANESTHESIA SYSTEM
K
93
0492
IDACARE ANESTHESIA MANAGEMENT WORKSTATIN
K
92
5580
OHMEDA TEC 6 (CFV) CONTINUOUS FLOW VAPORIZER, NAD
K
92
1742
OHMEDA AUTOCLAVABLE BELLOWS ASSEMBLY
K
91
3791
OHMEDA 7800 ANESTHESIA VENTILATOR
K
92
3519
SENSOR GUI
K
92
0944
FTS-200 GAS SYSTEM
K
90
5635
OHMEDA MODULUS CD ANESTHESIA SYSTEM
K
90
3991
PCM ANESTHESIA
K
90
3135
CLINI-CALC
K
90
1117
OHMEDA UNIVERSAL PAC
K
90
2962
LIFELOG(TM)
K
90
1713
NARKOMED 4 ANESTHESIA SYSTEM
K
90
1119
OHMEDA MODULUS CD ANESTHESIA SYSTEM
K
89
3780
OHMEDA EXCEL MRI COMPATIBLE ANESTHESIA SYSTEM
K
90
0937
O.R. DATA MANAGER
K
90
0328
NARKOMED 2B ANESTHESIA SYSTEM
K
90
0329
NARKOMED 3 ANESTHESIA SYSTEM
K
89
4309
OHMEDA MODULUS CD ANESTHESIA SYSTEM
K
88
4802
CAVENDISH 460/680 ANESTHESIA MACHINE
K
88
4991
CARDIOCAP CCK-104 KEYBOARD & CCP-104 GRAPHICS PRIN
K
89
0410
REVISED OHMEDA MODULUS II ANESTHESIA GAS MACHINE
K
88
4879
CENTURION(TM) MIXER
K
88
2489
REVISED PNEUMATIC DIAGRAMS FOR MODULUS II PLUS
K
87
5350
OHMEDA MODULUS II PLUS ANESTHESIA SYSTEM
K
87
2178
MODIFICATION TO ARKIVE(TM)
K
86
4589
TRI-SERVICE OMV VAPORIZER
K
86
4590
AM1000
K
86
4644
PHOENIX-C ANESTHESIA MACHINE
K
86
4447
NARKOMED 2B ANESTHESIA SYSTEM
K
86
4806
ANESTHESIA RECORDER
K
86
2085
ARKIVE (TM)
K
86
3207
OHMEDA 'B' SERIES GAS DELIVERY SYSTEM
K
86
2831
MODIFIED OHMEDA PAC PORTABLE ANESTHESIA SYSTEM
K
86
1170
NARKOMED 3 ANESTHESIA SYSTEM (MODIFIED)
K
85
5022
COMPUTERIZED ANESTHESIA RECORDING & INFO NETWORK
K
85
3435
NARKOMED 3 ANESTHESIA SYSTEM
K
85
4213
ARI STANDARD ANESTHESIA RECORD
K
85
2175
PATIENT DATA SYSTEMS CVA
K
85
3139
PHOENIX ANESTHESIA MACHINE
K
85
0648
OHMEDA PAC PORTABLE ANESTHESIA SYSTEM
K
84
4563
PHOENIX ANESTHESIA MACHINE
K
84
4849
OHMEDA MDM ELECTRONIC-GAS MACHINE FOR ANALGESIA
K
85
1621
BOOM ARM
K
84
4008
PENLON AM1000 ANAESTHESIA MACHINE
K
84
4421
FOREGGER DOME VALVES
K
84
4012
OHMEDA ANESTHESIA RECORD KEEPER
K
84
1370
KMA-1300F
K
84
0356
OHIO UNITROL II ANESTHESIA GAS MACHINE
K
84
1274
BAG-TO-VENTILATOR SELECTOR VALVE
K
83
3147
CENTRALERT
K
83
3335
MODULUS II ANESTHESIA GAS MACHINE
K
83
3151
BOYLE SYSTEM ANESTHESIA GAS MACHINE
K
83
0680
AIR-SHIELDS VENTIMETER VENTILATOR-CONTR
K
83
0160
ANESTHESIA APPARATUS #FO 20S
K
83
0161
ANESTHESIA APATATUS #D-25
K
83
0159
ANESTHESIA APPARATUS PH-35
K
82
2218
NARKOMED 2A ANESTHESIA MACHINE
K
80
3052
NUFFIELD ANESTHESIA VENTILATOR SER. 400
K
80
2591
MODEL 5460 + 5480 POP-OFF VALVES
K
80
1102
COMPALOR-ORAL SURGERY MODEL
K
80
1100
ANALOR FOUR-DENTAL MODEL
K
80
1103
COMPALOR-DENTAL MODEL
K
80
0801
ANALGESIA UNITS, OXYGEN & NITRATE DEVICE
K
79
1530
OHIO MODULAR ANESTHESIA GAS MACHINE
K
79
0456
SERIES 7000
K
78
1492
SERIES 7000 GAS MACHINE
K
77
1989
CONTINUOUS FLOW ANESTHESIA MACHINE
K
77
1479
NITROX 30 - ANESTHETIC GAS PROPORTIONER
K
77
1057
ANESTHESIA MACHINE
K
77
0554
NARKOMED ANESTHESIA MACHINE
K
76
0228
ANESTHESIA MACHINE, CHEMETRON
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
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
/
BSZ
/
K001988
View Source
MODULAR
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K001988
510(k) Type
Traditional
Applicant
HEYER AMERICA, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/5/2001
Days to Decision
221 days
Submission Type
Summary