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
K
22
1841
EOlife®
2
Cleared 510(K)
K
21
2905
Sotair Device
2
Cleared 510(K)
K
21
0288
Disposable Manual Resuscitator
2
Cleared 510(K)
K
18
1583
Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20
2
Cleared 510(K)
K
17
0663
Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer
2
Cleared 510(K)
K
15
2931
Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator
2
Cleared 510(K)
K
13
2172
NEONATALIE RESUSCITATOR
2
Cleared 510(K)
K
11
2852
BABI PLUS NEONATAL RESUSCITATION BAG
2
Cleared 510(K)
K
10
2824
AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC
2
Cleared 510(K)
K
10
2649
NEOPOP INFANT RESUSCITATOR WITH FLOW METER
2
Cleared 510(K)
K
09
4003
REVIVATOR
2
Cleared 510(K)
K
09
3081
POCKET BVM
2
Cleared 510(K)
K
08
2092
DISPO-BAG MANUAL RESUSCITATOR, DISPOSABLE ADJUSTABLE PEEP VALVE, DISPOSABLE FIXED PEEP VALVE
2
Cleared 510(K)
K
07
3410
SAVE RESUSCITATOR
2
Cleared 510(K)
K
07
3171
RESUSCITATION TIMER, MODEL L770-CPR
2
Cleared 510(K)
K
07
2021
NEOPIP INFANT RESUSCITATOR
2
Cleared 510(K)
K
07
0247
GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM
2
Cleared 510(K)
K
06
2080
RESUSCITATION TIMER, MODEL L770-CPR
2
Cleared 510(K)
K
05
3466
HSINER RESUSCITATOR
2
Cleared 510(K)
K
05
3140
AMBU MARK IV RESUSCITATOR
2
Cleared 510(K)
K
05
3142
AMBU MARK IV BABY RESUSCITATOR
2
Cleared 510(K)
K
05
1177
PVC AND SILICONE MANUAL RESUSCITATORS
2
Cleared 510(K)
K
04
2556
SHINEBALL PVC MANUAL RESUSCIATOR, ENT-1001, ENT-1003, ENT-1005, SHINEBALL SILICONE MANUAL RESUSCIATOR, ENT-1022,
2
Cleared 510(K)
K
04
2682
AMBU SPUR II. ADULT SINGLE PATIENT RESUSCITATOR
2
Cleared 510(K)
K
04
2843
AMBU SPUR II INFANT AND PEDIATRIC SINGLE PATIENT USE RESUSCITATORS
2
Cleared 510(K)
K
03
2596
STURDY MANUAL RESUSCITATOR
2
Cleared 510(K)
K
03
1395
MERLIN RESUSCITATOR
2
Cleared 510(K)
K
03
1434
BAWMED E-Z BAG RESUSCITATOR
2
Cleared 510(K)
K
03
0864
VADI MANUAL RESUSCITATOR
2
Cleared 510(K)
K
02
1328
SMART BAG MO
2
Cleared 510(K)
K
02
3793
1ST RESPONSE INTERMEDIATE MANUAL RESUSCITATOR
2
Cleared 510(K)
K
02
3494
NELLCOR INDGO MANUAL RESUSCITATOR
2
Cleared 510(K)
K
02
1446
OEMEDIC INTERNATIONAL INC. BESMED SILICONE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH MASK AND RESERVOIR
2
Cleared 510(K)
K
02
1716
SIMPLIFY COMPACT RESUSCITATOR
2
Cleared 510(K)
K
02
1390
PMX COMPACT RESUCITATOR
2
Cleared 510(K)
K
01
2271
ACUTEVENTILATOR
2
Cleared 510(K)
K
01
4071
PMX DISPOSABLE BAG MASK RESUSCITATOR
2
Cleared 510(K)
K
02
1442
OEMEDIC INTERNATIONAL INC. BESMED SINGLE USE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH MASK & RESERVOIR
2
Cleared 510(K)
K
01
4115
1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX
2
Cleared 510(K)
K
01
2842
V*CARE MANUAL RESUSCITATOR
2
Cleared 510(K)
K
00
3927
Y2000 MANUAL RESUSCITATOR, MODEL RUGU01/RUG02 AND RUGH01/RUGH02
2
Cleared 510(K)
K
00
2846
HEADSTAR'S MANUAL EMERGENCY RESUSCITATOR
2
Cleared 510(K)
K
99
3278
AMBU NEONATE SILICONE RESUSCITATOR
2
Cleared 510(K)
K
99
3194
RUSCH MANUAL RESUSCITATOR BAG
2
Cleared 510(K)
K
99
1861
1ST RESPONSE INFANT MANUAL RESUSCITATOR, BAG RESEVOIR, 1ST RESPONSE PEDIATRIC MANUAL RESUSCITATOR, BAG RESERVOIR, 1ST RE
2
Cleared 510(K)
K
99
2057
IST RESPONSE MANUAL RESUSCITATOR, MODELS, 008000, 008003,008006
2
Cleared 510(K)
K
99
1955
MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WITH CO2 DETECTION
2
Cleared 510(K)
K
99
1953
MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WITH CO2 DETECTION
2
Cleared 510(K)
K
98
2215
MANUAL RESUSCITATOR WITH ACE
2
Cleared 510(K)
K
98
0066
CPR FILTERSHIELD
2
Cleared 510(K)
K
98
1308
INTERNATIONAL RESPIRATORY SYSTEMS, INC.'S MANUAL PULMONARY RESUSCITATOR WITH RUBBER COMPRESSION BAG
2
Cleared 510(K)
K
98
1307
INTERNATIONAL RESPIRATORY SYSTEMS, INC.'S MANUAL RESUSCIATOR
2
Cleared 510(K)
K
97
4141
PLUS REUSABLE RESUSCITATOR
2
Cleared 510(K)
K
97
3419
DMR PLUS DISPOSABLE MANUAL RESUSCITATOR
2
Cleared 510(K)
K
97
3106
GOLEMB DISPOSABLE BAG MASK RESUSCITATOR
2
Cleared 510(K)
K
97
1243
OHMEDA INFANT RESUSCITATION SYSTEM
2
Cleared 510(K)
K
97
0756
MERCURY MEDICAL REUSABLE CPR BAG
2
Cleared 510(K)
K
97
2283
SIMS 1ST RESPONSE MANUAL RESUSCITATOR, ADULT
2
Cleared 510(K)
K
97
2139
ASPR-CARE CLOSED SYSTEM,DUAL SWIVEL PIECE T,SHEATHED SUCTION CATHETER,BRONCHOSOPE ADAPTER,IN-LINE SPECIMEN TRAP
2
Cleared 510(K)
K
96
3848
MANUAL RESUSCITATOR
2
Cleared 510(K)
K
97
0991
DATEX ENGSTOM MANUAL RESUSCITATOR
2
Cleared 510(K)
K
97
0959
INSTANT FLOW VAVLE (FLOWMETER, POLE, RAIL, WALL MOUNT)
2
Cleared 510(K)
K
96
4584
AMBU SPUR NEONATE
2
Cleared 510(K)
K
96
4719
HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR
2
Cleared 510(K)
K
95
5507
GRAYCO POCKET PUMP
2
Cleared 510(K)
K
96
1330
BAGRIGHT INFANT RESUSCITATOR
2
Cleared 510(K)
K
96
1329
BAGRIGHT CHILD RESUSCITATOR
2
Cleared 510(K)
K
96
1868
RESPOSABLE CHILD RESUSCITATOR
2
Cleared 510(K)
K
96
1882
RESPOSABLE INFANT RESUSCITATOR
2
Cleared 510(K)
K
96
1369
BAGRIGHT RESPOSABLE RESUSCITATOR
2
Cleared 510(K)
K
96
1332
BAGRIGHT RESPOSABLE INFANT RESUSCITATOR
2
Cleared 510(K)
K
96
1331
BAGRIGHT RESPOSABLE CHILD RESUSCITATOR
2
Cleared 510(K)
K
96
0468
DMR/CO2 COMBO KTI
2
Cleared 510(K)
K
95
3546
MANUAL PULMONARY RESUSICITATOR
2
Cleared 510(K)
K
95
4866
MERCURY CPR (COMPLETE PERSONAL RESUSCIATOR) BAG WITH EXPANDABLE RESERVOIR
2
Cleared 510(K)
K
95
4296
BAGRIGHT RESUSCITATOR
2
Cleared 510(K)
K
95
4150
VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
2
Cleared 510(K)
K
95
3617
RESPOSABLE RESUSCITATOR
2
Cleared 510(K)
K
95
3824
LIFEMASK FACE SHIELD
2
Cleared 510(K)
K
95
2512
CAPNO-FLO REGULATOR, CAPNO-FLO
2
Cleared 510(K)
K
95
2169
SAFE RESPONSE MOUTH-TO-MASK RESUSCITATOR, PEDIATRIC
2
Cleared 510(K)
K
93
4699
RESPIRONICS BAGEASY ENCOR ADULT SEMI-REUSABLE
2
Cleared 510(K)
K
94
4301
HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR CATALOG NUMBERS: 5360 THROUGH 5380
2
Cleared 510(K)
K
94
4347
PURITAN-BENNETT DISPOSABLE MANUAL RESUSCITATOR (DMR)
2
Cleared 510(K)
K
92
1982
MATRX HOPE(R) 5 RESUSCITATOR
2
Cleared 510(K)
K
94
1037
BNOS MICRO VENT, MODEL AC AND MODEL AO
2
Cleared 510(K)
K
94
3617
DISPOSABLE MANUAL RESUSCITATOR
2
Cleared 510(K)
K
94
0581
BAGEASY(R) III CHILD/INFANT DISPOS MAN RESUSCITATORS
2
Cleared 510(K)
K
93
4310
BAGEASY(R) III ADULT DISPOSABLE MANUAL RESUSCITATOR
2
Cleared 510(K)
K
92
2819
INFANT DISPOSABLE BAG MASK RESUSCITATOR
2
Cleared 510(K)
K
92
2691
LSP (MODEL 554) BAG MASK RESUSCITATOR
2
Cleared 510(K)
K
93
3626
CAPNO-FLO
2
Cleared 510(K)
K
93
2797
PRESSURE LIMITING ELBOW
2
Cleared 510(K)
K
92
4671
BAXTER ADULT/PEDI INFANT SINGLE/USE MAN RESUSCIT
2
Cleared 510(K)
K
92
4610
BAXTER ADULT/PEDI/INFANT SINGLE USE MAN RESUSCIT
2
Cleared 510(K)
K
93
0429
AID, CARDIOPULMONARY RESUSCITATION
2
Cleared 510(K)
K
92
3762
SPUR INFANT/CHILD W/O PRESSURE-LIMITING VALVE
2
Cleared 510(K)
K
91
3474
RESPIRE DISPOSABLE PULMONARY RESUSCITATOR
2
Cleared 510(K)
K
92
2810
ODYSSEY
2
Cleared 510(K)
K
91
3714
MODIFICATION MANUAL PULMON RESUSCITOR/PULMANEX(TM)
2
Cleared 510(K)
K
92
1553
LSPI INFANT BAG MASK
2
Cleared 510(K)
K
92
1002
RONDEX MASK MODELS 9122/9111/9102/911102, MODIFIED
2
Cleared 510(K)
K
92
4217
LSPI DISPOSABLE BAG MASK RESUSCITATOR/MODIFIED
2
Cleared 510(K)
K
92
4215
AMBU SILICONE RESUSCITATOR, ADULT W/OPEN RESERVOIR
2
Cleared 510(K)
K
92
4216
AMBU SILICONE RESUSCITATOR INFAN/CHILD W/OPEN RESO
2
Cleared 510(K)
K
92
2707
SPUR ADULT WITH OPEN RESERVOIR SYSTEM
2
Cleared 510(K)
K
92
2712
SPUR INFANT/CHILD WITH OPEN RESERVOIR SYSTEM
2
Cleared 510(K)
K
92
2004
MODIFICATION PURITAN-BENNETT INFANT PM2
2
Cleared 510(K)
K
91
5810
MER BAG
2
Cleared 510(K)
K
92
0570
PURITAN-BENNET INFANT MANUAL RESUSCITATOR MODIFIED
2
Cleared 510(K)
K
91
3900
V*CARE MANUAL RESUSCITATOR, CAT#VR-1000
2
Cleared 510(K)
K
91
2620
OPOMAT MANUAL RESUSCITATOR VENTILATOR
2
Cleared 510(K)
K
91
2203
EMS SINGLE USE MANUAL RESUSCITATORS
2
Cleared 510(K)
K
91
4196
RONDEX MASKS MODELS 9015/9011/901102 MODIFIED
2
Cleared 510(K)
K
91
4187
AMBU SILICONE RESUSCITATOR INFANT/CHILD
2
Cleared 510(K)
K
91
3370
MODIFICATION MANUAL RESUSCITATOR (PMR 2)
2
Cleared 510(K)
K
91
1971
MODIFIED SINGLE PATIENT USE DISP. MANUAL RESUSCIT.
2
Cleared 510(K)
K
91
2625
MOUTH TO MASK RESUSCITATOR
2
Cleared 510(K)
K
90
4899
VITAL SIGNS CODE BLUE ADULT MANUAL RESUSCITATOR
2
Cleared 510(K)
K
91
1298
PRESSURE LIMITING ELBOW WITH MANOMETER PORT
2
Cleared 510(K)
K
91
0856
MANUAL RESUSCITATOR
2
Cleared 510(K)
K
91
0040
AMBU SIR 2 (SILICONE RESUSCITATOR), ADULT
2
Cleared 510(K)
K
91
1622
CPR BAG
2
Cleared 510(K)
K
90
5304
DRESSER ARGUS P/N 1818
2
Cleared 510(K)
K
90
5002
SINGLE USE MANUAL RESUSCITATORS
2
Cleared 510(K)
K
90
4346
BAUMAN CPR/RESUSCITATOR
2
Cleared 510(K)
K
90
2733
1ST RESPONSE (TM) INFANT MANUAL RESUSCITATOR
2
Cleared 510(K)
K
90
3631
INFANT MANUAL RESUSCITATOR (PMR 2)
2
Cleared 510(K)
K
90
3570
SINGLE PATIENT USE INFANT DISPOSABLE MANUAL RESUSC
2
Cleared 510(K)
K
90
3443
MODIFIED SINGLE PATIENT USE DISP MAN RESUSCITATOR
2
Cleared 510(K)
K
90
3438
MOD PURITAN BENNETT SING PATIENT DISPOS MAN RESUS
2
Cleared 510(K)
K
90
2261
AMBU SPUR (SINGLE PATIENT USE RESUSCITATOR) INFANT
2
Cleared 510(K)
K
90
0577
1ST RESPONSE REUSABLE MANUAL RESUSCITATOR (ADULT)
2
Cleared 510(K)
K
90
0260
AMBU LIFE KEY AND AMBU RES-CUE KEY
2
Cleared 510(K)
K
90
1218
LIFE AID RESUSCITATOR
2
Cleared 510(K)
K
90
0349
PURITAN BENNETT SINGLE PATIENT USE PEEP ADAPTER
2
Cleared 510(K)
K
89
5820
RESUSO MASK
2
Cleared 510(K)
K
89
5589
MANUAL RESUSCITATOR
2
Cleared 510(K)
K
89
6886
ARTEC RESPOND PULMONARY RESUSCITATOR
2
Cleared 510(K)
K
89
5351
RESPIRONICS INFANT BAGEASY
2
Cleared 510(K)
K
89
5169
MANUAL DISPOSABLE PULMONARY RESUSCITATOR
2
Cleared 510(K)
K
89
4365
SINGLE PATIENT USE DISPOSABLE MANUAL RESUSCITATOR
2
Cleared 510(K)
K
88
5243
NEOVO2R VENTILATORY
2
Cleared 510(K)
K
89
2221
PULMONARY RESUSCITATOR, MODIFICATION
2
Cleared 510(K)
K
88
1881
OXYGENATION CATHETER
2
Cleared 510(K)
K
88
1483
AIRWAY-CIRCULATION EVALUATOR
2
Cleared 510(K)
K
88
4526
ADULT RESUSCITATOR WITH MASK AND FILTER
2
Cleared 510(K)
K
88
4068
PULMANEX TM (NEO-NATAL SIZE)
2
Cleared 510(K)
K
88
3434
AMBU SPUR (SINGLE PATIENT USE RESUSCITATOR)
2
Cleared 510(K)
K
88
2285
NONREBREATHING CIRCUIT
2
Cleared 510(K)
K
88
1207
RES-Q 1, 2, 3, 4 AND 5
2
Cleared 510(K)
K
88
1686
CPR BAG
2
Cleared 510(K)
K
88
2278
RESUSCITATION BAG CONTROLLER (RBC)
2
Cleared 510(K)
K
88
1086
LIFEGUARD MOUTH TO MASK RESUSCITATOR
2
Cleared 510(K)
K
88
1087
LIFEGUARD SINGLE USE MANUAL RESUSCITATORS
2
Cleared 510(K)
K
88
0450
RESUSCI PATIENT FACE SHIELD
2
Cleared 510(K)
K
88
0394
FIRST RESPONSE PEDIATRIC EMERGENCY RESUSCITATOR
2
Cleared 510(K)
K
87
4567
RESUSCITATOR
2
Cleared 510(K)
K
87
4418
LSP DISPOSABLE BAG RESUSCITATOR, MODEL 470
2
Cleared 510(K)
K
87
5077
HERCO SILICONE RESUSCITATOR OR SUN-MED RESUSCITA.
2
Cleared 510(K)
K
87
4321
SOLCO SILICONE RESUSCITATOR
2
Cleared 510(K)
K
87
3286
DISPOSABLE, MANUAL PULMONARY RESUSCITATOR
2
Cleared 510(K)
K
87
3043
MOUTH TO FACE RESUSCITATOR
2
Cleared 510(K)
K
87
1147
MODIFIED CPREVIVER
2
Cleared 510(K)
K
86
4308
BAUMAN CPR/RESPIRATOR
2
Cleared 510(K)
K
86
4125
CPREVIVER
2
Cleared 510(K)
K
86
3026
PULMANEX TM (MODIFICATION)
2
Cleared 510(K)
K
86
0693
PULMANEX (TM)
2
Cleared 510(K)
K
86
0180
MODEL 446 & 447 MOUTH TO MASK RESUSCITATOR
2
Cleared 510(K)
K
85
4037
PULMANEX
2
Cleared 510(K)
K
85
1171
COMBIBAG MANUAL RESUSCITATOR
2
Cleared 510(K)
K
85
2096
RESUS-AID DISPOSABLE RESUSCITATION SHIELD
2
Cleared 510(K)
K
84
4729
RESUSCITATOR, PULMONARY, MANUAL
2
Cleared 510(K)
K
85
0436
STAT BLUE DISPOS. MANUAL RESUSCITATOR
2
Cleared 510(K)
K
84
4420
MED-LIFE EMERGENCY OXYGEN REGREATHER/RESUSCITATOR
2
Cleared 510(K)
K
84
3223
FLOW CONTROLLER
2
Cleared 510(K)
K
84
2693
RESPIRONICS VENTEASY
2
Cleared 510(K)
K
84
2696
LIFE-MASK INFANT RESUSCITATOR
2
Cleared 510(K)
K
84
2487
SAMSON'S NEWBORN LUNG INFLATOR 340-1000
2
Cleared 510(K)
K
84
1496
FRASER HARLAKE HOPE III RESUSCITATOR
2
Cleared 510(K)
K
84
0935
MANUAL RESUSCITATION SYSTEM
2
Cleared 510(K)
K
84
0349
MARK III RESUSCITATOR
2
Cleared 510(K)
K
83
4250
RESCUE MASK
2
Cleared 510(K)
K
83
4400
FLYNN III-CHILD BAG-MASK UNIT ETC
2
Cleared 510(K)
K
83
3244
REVIVE
2
Cleared 510(K)
K
83
2495
FLYNN SERIES III BAG/MASK UNIT-
2
Cleared 510(K)
K
83
1885
CODE BLUE MANUAL RESUSCITATOR
2
Cleared 510(K)
K
83
1486
SC-603 TWIN VALVE
2
Cleared 510(K)
K
83
1198
CPR HEARTSAVER AND BREATHOLATOR
2
Cleared 510(K)
K
82
3710
DISPOSABLE AIRWAY ADEJUNCT
2
Cleared 510(K)
K
82
3408
BE#1000-INSTANT ON/OFF O2 VALVE
2
Cleared 510(K)
K
82
2213
SIEMENS-ELEMA AB AGA REVIVATOR
2
Cleared 510(K)
K
82
2356
MODULAIDE EMERG. CARDIAC LIFE SUPP. KT
2
Cleared 510(K)
K
82
0059
RESUSCITATION MASK
2
Cleared 510(K)
K
81
2273
RESUSCITATION CIRCUIT
2
Cleared 510(K)
K
81
2022
ZEE MANUAL RESUSCITATOR
2
Cleared 510(K)
K
80
3066
DISPOSABLE BAG MASK ADEJUNCT
2
Cleared 510(K)
K
80
2813
PMR-2 PURITAN MANUAL RESUSCITATOR
2
Cleared 510(K)
K
80
2231
AIR VIVA II
2
Cleared 510(K)
K
80
2081
AULD BAGGER KIT
2
Cleared 510(K)
K
79
2118
AIR-SHIELDS RESUSCITATORS
2
Cleared 510(K)
K
79
1468
RESUSCI-BAG-VALVE
2
Cleared 510(K)
K
78
0216
LIFESAVER, MANUAL #5160
2
Cleared 510(K)
K
77
1350
AMBU RESUSCITATOR
2
Cleared 510(K)
K
77
1175
RESUSCITATOR, MS30
2
Cleared 510(K)
K
76
1065
NEONATAL RESUSCITATOR, SAMSON
2
Cleared 510(K)
K
76
1025
BAG RESUSCITATOR
2
Cleared 510(K)
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 16 August 2024 at 11:05 pm
AN
/
subpart-f—therapeutic-devices
/
BTM
/
K894365
View Source
SINGLE PATIENT USE DISPOSABLE MANUAL RESUSCITATOR
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K894365
510(k) Type
Traditional
Applicant
PURITAN BENNETT CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/6/1989
Days to Decision
84 days
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)
K
22
1841
EOlife®
K
21
2905
Sotair Device
K
21
0288
Disposable Manual Resuscitator
K
18
1583
Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20
K
17
0663
Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer
K
15
2931
Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator
K
13
2172
NEONATALIE RESUSCITATOR
K
11
2852
BABI PLUS NEONATAL RESUSCITATION BAG
K
10
2824
AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC
K
10
2649
NEOPOP INFANT RESUSCITATOR WITH FLOW METER
K
09
4003
REVIVATOR
K
09
3081
POCKET BVM
K
08
2092
DISPO-BAG MANUAL RESUSCITATOR, DISPOSABLE ADJUSTABLE PEEP VALVE, DISPOSABLE FIXED PEEP VALVE
K
07
3410
SAVE RESUSCITATOR
K
07
3171
RESUSCITATION TIMER, MODEL L770-CPR
K
07
2021
NEOPIP INFANT RESUSCITATOR
K
07
0247
GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM
K
06
2080
RESUSCITATION TIMER, MODEL L770-CPR
K
05
3466
HSINER RESUSCITATOR
K
05
3140
AMBU MARK IV RESUSCITATOR
K
05
3142
AMBU MARK IV BABY RESUSCITATOR
K
05
1177
PVC AND SILICONE MANUAL RESUSCITATORS
K
04
2556
SHINEBALL PVC MANUAL RESUSCIATOR, ENT-1001, ENT-1003, ENT-1005, SHINEBALL SILICONE MANUAL RESUSCIATOR, ENT-1022,
K
04
2682
AMBU SPUR II. ADULT SINGLE PATIENT RESUSCITATOR
K
04
2843
AMBU SPUR II INFANT AND PEDIATRIC SINGLE PATIENT USE RESUSCITATORS
K
03
2596
STURDY MANUAL RESUSCITATOR
K
03
1395
MERLIN RESUSCITATOR
K
03
1434
BAWMED E-Z BAG RESUSCITATOR
K
03
0864
VADI MANUAL RESUSCITATOR
K
02
1328
SMART BAG MO
K
02
3793
1ST RESPONSE INTERMEDIATE MANUAL RESUSCITATOR
K
02
3494
NELLCOR INDGO MANUAL RESUSCITATOR
K
02
1446
OEMEDIC INTERNATIONAL INC. BESMED SILICONE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH MASK AND RESERVOIR
K
02
1716
SIMPLIFY COMPACT RESUSCITATOR
K
02
1390
PMX COMPACT RESUCITATOR
K
01
2271
ACUTEVENTILATOR
K
01
4071
PMX DISPOSABLE BAG MASK RESUSCITATOR
K
02
1442
OEMEDIC INTERNATIONAL INC. BESMED SINGLE USE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH MASK & RESERVOIR
K
01
4115
1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX
K
01
2842
V*CARE MANUAL RESUSCITATOR
K
00
3927
Y2000 MANUAL RESUSCITATOR, MODEL RUGU01/RUG02 AND RUGH01/RUGH02
K
00
2846
HEADSTAR'S MANUAL EMERGENCY RESUSCITATOR
K
99
3278
AMBU NEONATE SILICONE RESUSCITATOR
K
99
3194
RUSCH MANUAL RESUSCITATOR BAG
K
99
1861
1ST RESPONSE INFANT MANUAL RESUSCITATOR, BAG RESEVOIR, 1ST RESPONSE PEDIATRIC MANUAL RESUSCITATOR, BAG RESERVOIR, 1ST RE
K
99
2057
IST RESPONSE MANUAL RESUSCITATOR, MODELS, 008000, 008003,008006
K
99
1955
MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WITH CO2 DETECTION
K
99
1953
MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WITH CO2 DETECTION
K
98
2215
MANUAL RESUSCITATOR WITH ACE
K
98
0066
CPR FILTERSHIELD
K
98
1308
INTERNATIONAL RESPIRATORY SYSTEMS, INC.'S MANUAL PULMONARY RESUSCITATOR WITH RUBBER COMPRESSION BAG
K
98
1307
INTERNATIONAL RESPIRATORY SYSTEMS, INC.'S MANUAL RESUSCIATOR
K
97
4141
PLUS REUSABLE RESUSCITATOR
K
97
3419
DMR PLUS DISPOSABLE MANUAL RESUSCITATOR
K
97
3106
GOLEMB DISPOSABLE BAG MASK RESUSCITATOR
K
97
1243
OHMEDA INFANT RESUSCITATION SYSTEM
K
97
0756
MERCURY MEDICAL REUSABLE CPR BAG
K
97
2283
SIMS 1ST RESPONSE MANUAL RESUSCITATOR, ADULT
K
97
2139
ASPR-CARE CLOSED SYSTEM,DUAL SWIVEL PIECE T,SHEATHED SUCTION CATHETER,BRONCHOSOPE ADAPTER,IN-LINE SPECIMEN TRAP
K
96
3848
MANUAL RESUSCITATOR
K
97
0991
DATEX ENGSTOM MANUAL RESUSCITATOR
K
97
0959
INSTANT FLOW VAVLE (FLOWMETER, POLE, RAIL, WALL MOUNT)
K
96
4584
AMBU SPUR NEONATE
K
96
4719
HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR
K
95
5507
GRAYCO POCKET PUMP
K
96
1330
BAGRIGHT INFANT RESUSCITATOR
K
96
1329
BAGRIGHT CHILD RESUSCITATOR
K
96
1868
RESPOSABLE CHILD RESUSCITATOR
K
96
1882
RESPOSABLE INFANT RESUSCITATOR
K
96
1369
BAGRIGHT RESPOSABLE RESUSCITATOR
K
96
1332
BAGRIGHT RESPOSABLE INFANT RESUSCITATOR
K
96
1331
BAGRIGHT RESPOSABLE CHILD RESUSCITATOR
K
96
0468
DMR/CO2 COMBO KTI
K
95
3546
MANUAL PULMONARY RESUSICITATOR
K
95
4866
MERCURY CPR (COMPLETE PERSONAL RESUSCIATOR) BAG WITH EXPANDABLE RESERVOIR
K
95
4296
BAGRIGHT RESUSCITATOR
K
95
4150
VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
K
95
3617
RESPOSABLE RESUSCITATOR
K
95
3824
LIFEMASK FACE SHIELD
K
95
2512
CAPNO-FLO REGULATOR, CAPNO-FLO
K
95
2169
SAFE RESPONSE MOUTH-TO-MASK RESUSCITATOR, PEDIATRIC
K
93
4699
RESPIRONICS BAGEASY ENCOR ADULT SEMI-REUSABLE
K
94
4301
HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR CATALOG NUMBERS: 5360 THROUGH 5380
K
94
4347
PURITAN-BENNETT DISPOSABLE MANUAL RESUSCITATOR (DMR)
K
92
1982
MATRX HOPE(R) 5 RESUSCITATOR
K
94
1037
BNOS MICRO VENT, MODEL AC AND MODEL AO
K
94
3617
DISPOSABLE MANUAL RESUSCITATOR
K
94
0581
BAGEASY(R) III CHILD/INFANT DISPOS MAN RESUSCITATORS
K
93
4310
BAGEASY(R) III ADULT DISPOSABLE MANUAL RESUSCITATOR
K
92
2819
INFANT DISPOSABLE BAG MASK RESUSCITATOR
K
92
2691
LSP (MODEL 554) BAG MASK RESUSCITATOR
K
93
3626
CAPNO-FLO
K
93
2797
PRESSURE LIMITING ELBOW
K
92
4671
BAXTER ADULT/PEDI INFANT SINGLE/USE MAN RESUSCIT
K
92
4610
BAXTER ADULT/PEDI/INFANT SINGLE USE MAN RESUSCIT
K
93
0429
AID, CARDIOPULMONARY RESUSCITATION
K
92
3762
SPUR INFANT/CHILD W/O PRESSURE-LIMITING VALVE
K
91
3474
RESPIRE DISPOSABLE PULMONARY RESUSCITATOR
K
92
2810
ODYSSEY
K
91
3714
MODIFICATION MANUAL PULMON RESUSCITOR/PULMANEX(TM)
K
92
1553
LSPI INFANT BAG MASK
K
92
1002
RONDEX MASK MODELS 9122/9111/9102/911102, MODIFIED
K
92
4217
LSPI DISPOSABLE BAG MASK RESUSCITATOR/MODIFIED
K
92
4215
AMBU SILICONE RESUSCITATOR, ADULT W/OPEN RESERVOIR
K
92
4216
AMBU SILICONE RESUSCITATOR INFAN/CHILD W/OPEN RESO
K
92
2707
SPUR ADULT WITH OPEN RESERVOIR SYSTEM
K
92
2712
SPUR INFANT/CHILD WITH OPEN RESERVOIR SYSTEM
K
92
2004
MODIFICATION PURITAN-BENNETT INFANT PM2
K
91
5810
MER BAG
K
92
0570
PURITAN-BENNET INFANT MANUAL RESUSCITATOR MODIFIED
K
91
3900
V*CARE MANUAL RESUSCITATOR, CAT#VR-1000
K
91
2620
OPOMAT MANUAL RESUSCITATOR VENTILATOR
K
91
2203
EMS SINGLE USE MANUAL RESUSCITATORS
K
91
4196
RONDEX MASKS MODELS 9015/9011/901102 MODIFIED
K
91
4187
AMBU SILICONE RESUSCITATOR INFANT/CHILD
K
91
3370
MODIFICATION MANUAL RESUSCITATOR (PMR 2)
K
91
1971
MODIFIED SINGLE PATIENT USE DISP. MANUAL RESUSCIT.
K
91
2625
MOUTH TO MASK RESUSCITATOR
K
90
4899
VITAL SIGNS CODE BLUE ADULT MANUAL RESUSCITATOR
K
91
1298
PRESSURE LIMITING ELBOW WITH MANOMETER PORT
K
91
0856
MANUAL RESUSCITATOR
K
91
0040
AMBU SIR 2 (SILICONE RESUSCITATOR), ADULT
K
91
1622
CPR BAG
K
90
5304
DRESSER ARGUS P/N 1818
K
90
5002
SINGLE USE MANUAL RESUSCITATORS
K
90
4346
BAUMAN CPR/RESUSCITATOR
K
90
2733
1ST RESPONSE (TM) INFANT MANUAL RESUSCITATOR
K
90
3631
INFANT MANUAL RESUSCITATOR (PMR 2)
K
90
3570
SINGLE PATIENT USE INFANT DISPOSABLE MANUAL RESUSC
K
90
3443
MODIFIED SINGLE PATIENT USE DISP MAN RESUSCITATOR
K
90
3438
MOD PURITAN BENNETT SING PATIENT DISPOS MAN RESUS
K
90
2261
AMBU SPUR (SINGLE PATIENT USE RESUSCITATOR) INFANT
K
90
0577
1ST RESPONSE REUSABLE MANUAL RESUSCITATOR (ADULT)
K
90
0260
AMBU LIFE KEY AND AMBU RES-CUE KEY
K
90
1218
LIFE AID RESUSCITATOR
K
90
0349
PURITAN BENNETT SINGLE PATIENT USE PEEP ADAPTER
K
89
5820
RESUSO MASK
K
89
5589
MANUAL RESUSCITATOR
K
89
6886
ARTEC RESPOND PULMONARY RESUSCITATOR
K
89
5351
RESPIRONICS INFANT BAGEASY
K
89
5169
MANUAL DISPOSABLE PULMONARY RESUSCITATOR
K
89
4365
SINGLE PATIENT USE DISPOSABLE MANUAL RESUSCITATOR
K
88
5243
NEOVO2R VENTILATORY
K
89
2221
PULMONARY RESUSCITATOR, MODIFICATION
K
88
1881
OXYGENATION CATHETER
K
88
1483
AIRWAY-CIRCULATION EVALUATOR
K
88
4526
ADULT RESUSCITATOR WITH MASK AND FILTER
K
88
4068
PULMANEX TM (NEO-NATAL SIZE)
K
88
3434
AMBU SPUR (SINGLE PATIENT USE RESUSCITATOR)
K
88
2285
NONREBREATHING CIRCUIT
K
88
1207
RES-Q 1, 2, 3, 4 AND 5
K
88
1686
CPR BAG
K
88
2278
RESUSCITATION BAG CONTROLLER (RBC)
K
88
1086
LIFEGUARD MOUTH TO MASK RESUSCITATOR
K
88
1087
LIFEGUARD SINGLE USE MANUAL RESUSCITATORS
K
88
0450
RESUSCI PATIENT FACE SHIELD
K
88
0394
FIRST RESPONSE PEDIATRIC EMERGENCY RESUSCITATOR
K
87
4567
RESUSCITATOR
K
87
4418
LSP DISPOSABLE BAG RESUSCITATOR, MODEL 470
K
87
5077
HERCO SILICONE RESUSCITATOR OR SUN-MED RESUSCITA.
K
87
4321
SOLCO SILICONE RESUSCITATOR
K
87
3286
DISPOSABLE, MANUAL PULMONARY RESUSCITATOR
K
87
3043
MOUTH TO FACE RESUSCITATOR
K
87
1147
MODIFIED CPREVIVER
K
86
4308
BAUMAN CPR/RESPIRATOR
K
86
4125
CPREVIVER
K
86
3026
PULMANEX TM (MODIFICATION)
K
86
0693
PULMANEX (TM)
K
86
0180
MODEL 446 & 447 MOUTH TO MASK RESUSCITATOR
K
85
4037
PULMANEX
K
85
1171
COMBIBAG MANUAL RESUSCITATOR
K
85
2096
RESUS-AID DISPOSABLE RESUSCITATION SHIELD
K
84
4729
RESUSCITATOR, PULMONARY, MANUAL
K
85
0436
STAT BLUE DISPOS. MANUAL RESUSCITATOR
K
84
4420
MED-LIFE EMERGENCY OXYGEN REGREATHER/RESUSCITATOR
K
84
3223
FLOW CONTROLLER
K
84
2693
RESPIRONICS VENTEASY
K
84
2696
LIFE-MASK INFANT RESUSCITATOR
K
84
2487
SAMSON'S NEWBORN LUNG INFLATOR 340-1000
K
84
1496
FRASER HARLAKE HOPE III RESUSCITATOR
K
84
0935
MANUAL RESUSCITATION SYSTEM
K
84
0349
MARK III RESUSCITATOR
K
83
4250
RESCUE MASK
K
83
4400
FLYNN III-CHILD BAG-MASK UNIT ETC
K
83
3244
REVIVE
K
83
2495
FLYNN SERIES III BAG/MASK UNIT-
K
83
1885
CODE BLUE MANUAL RESUSCITATOR
K
83
1486
SC-603 TWIN VALVE
K
83
1198
CPR HEARTSAVER AND BREATHOLATOR
K
82
3710
DISPOSABLE AIRWAY ADEJUNCT
K
82
3408
BE#1000-INSTANT ON/OFF O2 VALVE
K
82
2213
SIEMENS-ELEMA AB AGA REVIVATOR
K
82
2356
MODULAIDE EMERG. CARDIAC LIFE SUPP. KT
K
82
0059
RESUSCITATION MASK
K
81
2273
RESUSCITATION CIRCUIT
K
81
2022
ZEE MANUAL RESUSCITATOR
K
80
3066
DISPOSABLE BAG MASK ADEJUNCT
K
80
2813
PMR-2 PURITAN MANUAL RESUSCITATOR
K
80
2231
AIR VIVA II
K
80
2081
AULD BAGGER KIT
K
79
2118
AIR-SHIELDS RESUSCITATORS
K
79
1468
RESUSCI-BAG-VALVE
K
78
0216
LIFESAVER, MANUAL #5160
K
77
1350
AMBU RESUSCITATOR
K
77
1175
RESUSCITATOR, MS30
K
76
1065
NEONATAL RESUSCITATOR, SAMSON
K
76
1025
BAG 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
/
BTM
/
K894365
View Source
SINGLE PATIENT USE DISPOSABLE MANUAL RESUSCITATOR
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K894365
510(k) Type
Traditional
Applicant
PURITAN BENNETT CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/6/1989
Days to Decision
84 days