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BTM

209 FDA 510(k) clearances · Product code

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RecordFirmDate
ODYSSEY (K922810)O-Two Systems Intl., Inc.1993-01-22
MODIFICATION MANUAL PULMON RESUSCITOR/PULMANEX(TM) (K913714)Life Design Systems, Inc.1992-12-01
LSPI INFANT BAG MASK (K921553)Life Support Products, Inc.1992-10-19
RONDEX MASK MODELS 9122/9111/9102/911102, MODIFIED (K921002)Rondex Products, Inc.1992-10-06
LSPI DISPOSABLE BAG MASK RESUSCITATOR/MODIFIED (K924217)Life Support Products, Inc.1992-09-17
AMBU SILICONE RESUSCITATOR, ADULT W/OPEN RESERVOIR (K924215)Ambu, Inc.1992-09-16
AMBU SILICONE RESUSCITATOR INFAN/CHILD W/OPEN RESO (K924216)Ambu, Inc.1992-09-16
SPUR INFANT/CHILD WITH OPEN RESERVOIR SYSTEM (K922712)Ambu, Inc.1992-06-19
SPUR ADULT WITH OPEN RESERVOIR SYSTEM (K922707)Ambu, Inc.1992-06-19
MODIFICATION PURITAN-BENNETT INFANT PM2 (K922004)Puritan Bennett Corp.1992-05-28
MER BAG (K915810)Merced Medical, Inc.1992-03-09
PURITAN-BENNET INFANT MANUAL RESUSCITATOR MODIFIED (K920570)Puritan Bennett Corp.1992-02-27
V*CARE MANUAL RESUSCITATOR, CAT#VR-1000 (K913900)Ventlab Corp.1992-01-07
OPOMAT MANUAL RESUSCITATOR VENTILATOR (K912620)Euro-Am Pharma, Inc.1991-12-04
EMS SINGLE USE MANUAL RESUSCITATORS (K912203)Engineered Medical Systems1991-11-13
RONDEX MASKS MODELS 9015/9011/901102 MODIFIED (K914196)Rondex Products, Inc.1991-11-08
AMBU SILICONE RESUSCITATOR INFANT/CHILD (K914187)Ambu, Inc.1991-10-07
MODIFICATION MANUAL RESUSCITATOR (PMR 2) (K913370)Puritan Bennett Corp.1991-08-26
MODIFIED SINGLE PATIENT USE DISP. MANUAL RESUSCIT. (K911971)Puritan Bennett Corp.1991-08-09
MOUTH TO MASK RESUSCITATOR (K912625)Vital Signs, Inc.1991-08-02
VITAL SIGNS CODE BLUE ADULT MANUAL RESUSCITATOR (K904899)Vital Signs, Inc.1991-07-24
PRESSURE LIMITING ELBOW WITH MANOMETER PORT (K911298)Intertech Resources, Inc.1991-06-25
MANUAL RESUSCITATOR (K910856)Vital Signs, Inc.1991-06-18
AMBU SIR 2 (SILICONE RESUSCITATOR), ADULT (K910040)Ambu, Inc.1991-05-28
CPR BAG (K911622)Merced Medical, Inc.1991-05-20
DRESSER ARGUS P/N 1818 (K905304)Dresser Argus, Inc.1991-04-17
SINGLE USE MANUAL RESUSCITATORS (K905002)Custom Medical, Inc.1991-03-29
BAUMAN CPR/RESUSCITATOR (K904346)General Medical Products, Inc.1990-10-02
1ST RESPONSE (TM) INFANT MANUAL RESUSCITATOR (K902733)Intertech Resources, Inc.1990-08-22
SINGLE PATIENT USE INFANT DISPOSABLE MANUAL RESUSC (K903570)Puritan Bennett Corp.1990-08-17
MOD PURITAN BENNETT SING PATIENT DISPOS MAN RESUS (K903438)Puritan Bennett Corp.1990-08-17
MODIFIED SINGLE PATIENT USE DISP MAN RESUSCITATOR (K903443)Puritan Bennett Corp.1990-08-17
INFANT MANUAL RESUSCITATOR (PMR 2) (K903631)Puritan Bennett Corp.1990-08-17
AMBU SPUR (SINGLE PATIENT USE RESUSCITATOR) INFANT (K902261)Ambu, Inc.1990-07-16
1ST RESPONSE REUSABLE MANUAL RESUSCITATOR (ADULT) (K900577)Intertech Resources, Inc.1990-07-16
AMBU LIFE KEY AND AMBU RES-CUE KEY (K900260)Ambu, Inc.1990-06-08
LIFE AID RESUSCITATOR (K901218)Clarendon Supplies , Ltd.1990-05-18
PURITAN BENNETT SINGLE PATIENT USE PEEP ADAPTER (K900349)Puritan Bennett Corp.1990-05-01
RESUSO MASK (K895820)Rml Ent., Inc.1990-04-04
MANUAL RESUSCITATOR (K895589)Hudson Oxygen Therapy Sales Co.1990-03-30
ARTEC RESPOND PULMONARY RESUSCITATOR (K896886)Artec Environmental Monitoring Division1990-02-06
RESPIRONICS INFANT BAGEASY (K895351)Respironics, Inc.1989-10-27
MANUAL DISPOSABLE PULMONARY RESUSCITATOR (K895169)F.L.W. Plastics, Inc.1989-10-13
SINGLE PATIENT USE DISPOSABLE MANUAL RESUSCITATOR (K894365)Puritan Bennett Corp.1989-10-06
NEOVO2R VENTILATORY (K885243)Neomed1989-07-24
PULMONARY RESUSCITATOR, MODIFICATION (K892221)Life Design Systems, Inc.1989-05-18
OXYGENATION CATHETER (K881881)Ventech Healthcare Corp., Inc.1989-02-17
AIRWAY-CIRCULATION EVALUATOR (K881483)Resuscitation Ace, Inc.1988-12-16
ADULT RESUSCITATOR WITH MASK AND FILTER (K884526)Intertech/Ohio1988-11-16
PULMANEX TM (NEO-NATAL SIZE) (K884068)Life Design Systems, Inc.1988-11-16
AMBU SPUR (SINGLE PATIENT USE RESUSCITATOR) (K883434)Ambu, Inc.1988-09-14
NONREBREATHING CIRCUIT (K882285)Dryden Corp.1988-08-16
RES-Q 1, 2, 3, 4 AND 5 (K881207)Nova-Ventrx1988-08-15
CPR BAG (K881686)Devolve Corp.1988-06-23
RESUSCITATION BAG CONTROLLER (RBC) (K882278)Physician Engineered Products, Inc.1988-06-16
LIFEGUARD MOUTH TO MASK RESUSCITATOR (K881086)Lifeguard Medical Products, Inc.1988-04-14
LIFEGUARD SINGLE USE MANUAL RESUSCITATORS (K881087)Lifeguard Medical Products, Inc.1988-04-14
RESUSCI PATIENT FACE SHIELD (K880450)Laerdal Medical Corp.1988-03-04
FIRST RESPONSE PEDIATRIC EMERGENCY RESUSCITATOR (K880394)Intertech/Ohio1988-02-29
RESUSCITATOR (K874567)American Medical Technology, Inc.1988-02-29
LSP DISPOSABLE BAG RESUSCITATOR, MODEL 470 (K874418)Life Support Products, Inc.1988-01-22
SOLCO SILICONE RESUSCITATOR (K874321)Kahn-Tact U.S.A., Inc.1988-01-19
HERCO SILICONE RESUSCITATOR OR SUN-MED RESUSCITA. (K875077)Herco Products, Inc.1988-01-19
DISPOSABLE, MANUAL PULMONARY RESUSCITATOR (K873286)Hospitak, Inc.1987-10-26
MOUTH TO FACE RESUSCITATOR (K873043)Artec Environmental Monitoring Division1987-09-28
MODIFIED CPREVIVER (K871147)Augerscope, Inc.1987-04-20
BAUMAN CPR/RESPIRATOR (K864308)General Medical Products, Inc.1987-03-09
CPREVIVER (K864125)Augerscope, Inc.1987-02-26
PULMANEX TM (MODIFICATION) (K863026)Life Design Systems, Inc.1986-08-26
PULMANEX (TM) (K860693)Life Design Systems, Inc.1986-03-27
MODEL 446 & 447 MOUTH TO MASK RESUSCITATOR (K860180)Life Support Products, Inc.1986-03-06
PULMANEX (K854037)Life Design Systems, Inc.1985-11-01
COMBIBAG MANUAL RESUSCITATOR (K851171)Frontline Medical Corp.1985-09-06
RESUS-AID DISPOSABLE RESUSCITATION SHIELD (K852096)Emergency Situation Products1985-07-08
RESUSCITATOR, PULMONARY, MANUAL (K844729)Life Design Systems, Inc.1985-03-25
STAT BLUE DISPOS. MANUAL RESUSCITATOR (K850436)Vital Signs, Inc.1985-02-26
MED-LIFE EMERGENCY OXYGEN REGREATHER/RESUSCITATOR (K844420)Med-Life, Inc.1984-12-17
FLOW CONTROLLER (K843223)Precision Medical, Inc.1984-09-27
RESPIRONICS VENTEASY (K842693)Respironics, Inc.1984-08-10
LIFE-MASK INFANT RESUSCITATOR (K842696)Electronic Monitors, Inc.1984-07-27
SAMSON'S NEWBORN LUNG INFLATOR 340-1000 (K842487)J. H. Emerson Co.1984-07-06
FRASER HARLAKE HOPE III RESUSCITATOR (K841496)Fraser Harlake, Inc.1984-04-24
MANUAL RESUSCITATION SYSTEM (K840935)Inspiron Corp.1984-04-05
MARK III RESUSCITATOR (K840349)Ambu, Inc.1984-02-10
RESCUE MASK (K834250)Rondex Products, Inc.1984-01-18
FLYNN III-CHILD BAG-MASK UNIT ETC (K834400)O-Two Systems Intl., Inc.1984-01-13
REVIVE (K833244)Aladdin Industries, Inc.1983-11-29
FLYNN SERIES III BAG/MASK UNIT- (K832495)O-Two Systems Intl., Inc.1983-09-29
CODE BLUE MANUAL RESUSCITATOR (K831885)Vital Signs, Inc.1983-09-08
SC-603 TWIN VALVE (K831486)Instrumentation Industries, Inc.1983-08-12
CPR HEARTSAVER AND BREATHOLATOR (K831198)Cervco Corp.1983-06-24
DISPOSABLE AIRWAY ADEJUNCT (K823710)Groves Medical Supply, Inc.1983-01-21
BE#1000-INSTANT ON/OFF O2 VALVE (K823408)Instrumentation Industries, Inc.1982-12-07
SIEMENS-ELEMA AB AGA REVIVATOR (K822213)Siemens Elema AB1982-10-28
MODULAIDE EMERG. CARDIAC LIFE SUPP. KT (K822356)Laerdal Medical Corp.1982-08-20
RESUSCITATION MASK (K820059)Cederroth, Inc. USA1982-03-26
RESUSCITATION CIRCUIT (K812273)Vital Signs, Inc.1981-08-25
ZEE MANUAL RESUSCITATOR (K812022)Zee Medical Products Co., Inc.1981-07-31
DISPOSABLE BAG MASK ADEJUNCT (K803066)T. S. Enterprises, Inc.1981-02-12
PMR-2 PURITAN MANUAL RESUSCITATOR (K802813)Puritan Bennett Corp.1980-12-17
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