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Panels › Anesthesiology › Product code BTM · Class 2

Ventilator, Emergency, Manual (Resuscitator)

Regulation 868.5915

2510(k)s in 12 months (210 all time)
1recalls in 12 months (97 all time)
80recalls that name a 510(k)
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Top companies in BTM

Company510(k)sRecalls
Unomedical023
Ventlab Corp.219
Ambu, Inc.151
Sun Med, LLC014
Puritan Bennett Corp.130
Medical Marketing Concepts110
Vyaire Medical011
SunMed Holdings, LLC010
Laerdal Medical AS34
Life Design Systems, Inc.70
Decided510(k)Device and applicantCode
Feb 3, 1993K913474RESPIRE DISPOSABLE PULMONARY RESUSCITATOR
Med-Tek Innovations, Inc.
BTM
Jan 22, 1993K922810ODYSSEY
O-Two Systems Intl., Inc., CA
BTM
Dec 1, 1992K913714MODIFICATION MANUAL PULMON RESUSCITOR/PULMANEX(TM)
Life Design Systems, Inc.
BTM
Oct 19, 1992K921553LSPI INFANT BAG MASK
Life Support Products, Inc.
BTM
Oct 6, 1992K921002RONDEX MASK MODELS 9122/9111/9102/911102, MODIFIED
Rondex Products, Inc.
BTM
Sep 17, 1992K924217LSPI DISPOSABLE BAG MASK RESUSCITATOR/MODIFIED
Life Support Products, Inc.
BTM
Sep 16, 1992K924216AMBU SILICONE RESUSCITATOR INFAN/CHILD W/OPEN RESO
Ambu, Inc.
BTM
Sep 16, 1992K924215AMBU SILICONE RESUSCITATOR, ADULT W/OPEN RESERVOIR
Ambu, Inc.
BTM
Jun 19, 1992K922712SPUR INFANT/CHILD WITH OPEN RESERVOIR SYSTEM
Ambu, Inc.
BTM
Jun 19, 1992K922707SPUR ADULT WITH OPEN RESERVOIR SYSTEM
Ambu, Inc.
BTM
May 28, 1992K922004MODIFICATION PURITAN-BENNETT INFANT PM2
Puritan Bennett Corp.
BTM
Mar 9, 1992K915810MER BAG
Merced Medical, Inc.
BTM
Feb 27, 1992K920570PURITAN-BENNET INFANT MANUAL RESUSCITATOR MODIFIED
Puritan Bennett Corp.
BTM
Jan 7, 1992K913900V*CARE MANUAL RESUSCITATOR, CAT#VR-1000
Ventlab Corp.
BTM
Dec 4, 1991K912620OPOMAT MANUAL RESUSCITATOR VENTILATOR
Euro-Am Pharma, Inc.
BTM
Nov 13, 1991K912203EMS SINGLE USE MANUAL RESUSCITATORS
Engineered Medical Systems
BTM
Nov 8, 1991K914196RONDEX MASKS MODELS 9015/9011/901102 MODIFIED
Rondex Products, Inc.
BTM
Oct 7, 1991K914187AMBU SILICONE RESUSCITATOR INFANT/CHILD
Ambu, Inc.
BTM
Aug 26, 1991K913370MODIFICATION MANUAL RESUSCITATOR (PMR 2)
Puritan Bennett Corp.
BTM
Aug 9, 1991K911971MODIFIED SINGLE PATIENT USE DISP. MANUAL RESUSCIT.
Puritan Bennett Corp.
BTM
Aug 2, 1991K912625MOUTH TO MASK RESUSCITATOR
Vital Signs, Inc.
BTM
Jul 24, 1991K904899VITAL SIGNS CODE BLUE ADULT MANUAL RESUSCITATOR
Vital Signs, Inc.
BTM
Jun 25, 1991K911298PRESSURE LIMITING ELBOW WITH MANOMETER PORT
Intertech Resources, Inc.
BTM
Jun 18, 1991K910856MANUAL RESUSCITATOR
Vital Signs, Inc.
BTM
May 28, 1991K910040AMBU SIR 2 (SILICONE RESUSCITATOR), ADULT
Ambu, Inc.
BTM
May 20, 1991K911622CPR BAG
Merced Medical, Inc.
BTM
Apr 17, 1991K905304DRESSER ARGUS P/N 1818
Dresser Argus, Inc.
BTM
Mar 29, 1991K905002SINGLE USE MANUAL RESUSCITATORS
Custom Medical, Inc.
BTM
Oct 2, 1990K904346BAUMAN CPR/RESUSCITATOR
General Medical Products, Inc.
BTM
Aug 22, 1990K9027331ST RESPONSE (TM) INFANT MANUAL RESUSCITATOR
Intertech Resources, Inc.
BTM
Aug 17, 1990K903631INFANT MANUAL RESUSCITATOR (PMR 2)
Puritan Bennett Corp.
BTM
Aug 17, 1990K903570SINGLE PATIENT USE INFANT DISPOSABLE MANUAL RESUSC
Puritan Bennett Corp.
BTM
Aug 17, 1990K903443MODIFIED SINGLE PATIENT USE DISP MAN RESUSCITATOR
Puritan Bennett Corp.
BTM
Aug 17, 1990K903438MOD PURITAN BENNETT SING PATIENT DISPOS MAN RESUS
Puritan Bennett Corp.
BTM
Jul 16, 1990K902261AMBU SPUR (SINGLE PATIENT USE RESUSCITATOR) INFANT
Ambu, Inc.
BTM
Jul 16, 1990K9005771ST RESPONSE REUSABLE MANUAL RESUSCITATOR (ADULT)
Intertech Resources, Inc.
BTM
Jun 8, 1990K900260AMBU LIFE KEY AND AMBU RES-CUE KEY
Ambu, Inc.
BTM
May 18, 1990K901218LIFE AID RESUSCITATOR
Clarendon Supplies , Ltd., GB
BTM
May 1, 1990K900349PURITAN BENNETT SINGLE PATIENT USE PEEP ADAPTER
Puritan Bennett Corp.
BTM
Apr 4, 1990K895820RESUSO MASK
Rml Ent., Inc.
BTM
Mar 30, 1990K895589MANUAL RESUSCITATOR
Hudson Oxygen Therapy Sales Co.
BTM
Feb 6, 1990K896886ARTEC RESPOND PULMONARY RESUSCITATOR
Artec Environmental Monitoring Division
BTM
Oct 27, 1989K895351RESPIRONICS INFANT BAGEASY
Respironics, Inc.
BTM
Oct 13, 1989K895169MANUAL DISPOSABLE PULMONARY RESUSCITATOR
F.L.W. Plastics, Inc.
BTM
Oct 6, 1989K894365SINGLE PATIENT USE DISPOSABLE MANUAL RESUSCITATOR
Puritan Bennett Corp.
BTM
Jul 24, 1989K885243NEOVO2R VENTILATORY
Neomed, GB
BTM
May 18, 1989K892221PULMONARY RESUSCITATOR, MODIFICATION
Life Design Systems, Inc.
BTM
Feb 17, 1989K881881OXYGENATION CATHETER
Ventech Healthcare Corp., Inc.
BTM
Dec 16, 1988K881483AIRWAY-CIRCULATION EVALUATOR
Resuscitation Ace, Inc.
BTM
Nov 16, 1988K884526ADULT RESUSCITATOR WITH MASK AND FILTER
Intertech/Ohio
BTM

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