FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K112852 |
A PLUS MEDICAL |
BABI PLUS NEONATAL RESUSCITATION BAG |
01/13/2012 |
K973106 |
ALLIED HEALTHCARE PRODUCTS, INC. |
GOLEMB DISPOSABLE BAG MASK RESUSCITATOR |
01/29/1998 |
K014071 |
ALLIED HEALTHCARE PRODUCTS, INC. |
PMX DISPOSABLE BAG MASK RESUSCITATOR |
10/01/2002 |
K073171 |
ALLIED HEALTHCARE PRODUCTS, INC. |
RESUSCITATION TIMER, MODEL L770-CPR |
01/31/2008 |
K062080 |
ALLIED HEALTHCARE PRODUCTS, INC. |
RESUSCITATION TIMER, MODEL L770-CPR |
10/18/2006 |
K053142 |
AMBU A/S |
AMBU MARK IV BABY RESUSCITATOR |
12/20/2005 |
K053140 |
AMBU A/S |
AMBU MARK IV RESUSCITATOR |
12/23/2005 |
K102824 |
AMBU A/S |
AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC |
01/28/2011 |
K152931 |
AMBU A/S |
Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator |
08/29/2016 |
K993278 |
AMBU, INC. |
AMBU NEONATE SILICONE RESUSCITATOR |
05/17/2000 |
K042843 |
AMBU, INC. |
AMBU SPUR II INFANT AND PEDIATRIC SINGLE PATIENT USE RESUSCITATORS |
11/12/2004 |
K042682 |
AMBU, INC. |
AMBU SPUR II. ADULT SINGLE PATIENT RESUSCITATOR |
11/15/2004 |
K964584 |
AMBU, INC. |
AMBU SPUR NEONATE |
05/15/1997 |
K221841 |
ARCHEON |
EOlife« |
03/18/2023 |
K073410 |
ARTIVENT CORPORATION |
SAVE RESUSCITATOR |
09/12/2008 |
K031434 |
BAWMED UK |
BAWMED E-Z BAG RESUSCITATOR |
02/06/2004 |
K021390 |
CHEEN HOUNG ENT. CO. LTD. |
PMX COMPACT RESUCITATOR |
10/04/2002 |
K003927 |
CHEEN HOUNG ENT. CO. LTD. |
Y2000 MANUAL RESUSCITATOR, MODEL RUGU01/RUG02 AND RUGH01/RUGH02 |
06/26/2001 |
K051177 |
DAVID MEDICAL PRODUCTS CO.,LTD |
PVC AND SILICONE MANUAL RESUSCITATORS |
08/29/2005 |
K972139 |
DAVIS & GECK, INC. |
ASPR-CARE CLOSED SYSTEM,DUAL SWIVEL PIECE T,SHEATHED SUCTION CATHETER,BRONCHOSOPE ADAPTER,IN-LINE SPECIMEN TRAP |
09/03/1997 |
K991953 |
ENGINEERED MEDICAL SYSTEMS |
MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WITH CO2 DETECTION |
07/01/1999 |
K991955 |
ENGINEERED MEDICAL SYSTEMS |
MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WITH CO2 DETECTION |
07/06/1999 |
K042556 |
ENTER MEDICAL CORPORATION |
SHINEBALL PVC MANUAL RESUSCIATOR, ENT-1001, ENT-1003, ENT-1005, SHINEBALL SILICONE MANUAL RESUSCIATOR, ENT-1022, |
03/11/2005 |
K181583 |
Flexicare Medical Limited |
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 Si |
12/07/2018 |
K170663 |
Foremount Enterprise Co., Ltd. |
Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer |
05/11/2018 |
K082092 |
GALEMED CORP. |
DISPO-BAG MANUAL RESUSCITATOR, DISPOSABLE ADJUSTABLE PEEP VALVE, DISPOSABLE FIXED PEEP VALVE |
10/15/2008 |
K955507 |
GRAYCO, INC. |
GRAYCO POCKET PUMP |
08/15/1996 |
K002846 |
HEADSTAR MEDICAL PRODUCTS CO., LTD |
HEADSTAR'S MANUAL EMERGENCY RESUSCITATOR |
06/06/2001 |
K094003 |
HERSILL, S.L. |
REVIVATOR |
09/17/2010 |
K053466 |
HSINER CO., LTD. |
HSINER RESUSCITATOR |
03/22/2006 |
K964719 |
HUDSON RESPIRATORY CARE, INC. |
HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR |
02/21/1997 |
K012271 |
IMPOEX INTERNATIONAL, LTD. |
ACUTEVENTILATOR |
10/04/2002 |
K970959 |
INSTRUMENTATION INDUSTRIES, INC. |
INSTANT FLOW VAVLE (FLOWMETER, POLE, RAIL, WALL MOUNT) |
06/13/1997 |
K981308 |
INTERNATIONAL RESPIRATORY SYSTEMS, INC. |
INTERNATIONAL RESPIRATORY SYSTEMS, INC.'S MANUAL PULMONARY RESUSCITATOR WITH RUBBER COMPRESSION BAG |
07/06/1998 |
K981307 |
INTERNATIONAL RESPIRATORY SYSTEMS, INC. |
INTERNATIONAL RESPIRATORY SYSTEMS, INC.'S MANUAL RESUSCIATOR |
07/06/1998 |
K132172 |
LAERDAL MEDICAL A/S |
NEONATALIE RESUSCITATOR |
01/15/2015 |
K961329 |
MEDICAL MARKETING CONCEPTS |
BAGRIGHT CHILD RESUSCITATOR |
07/02/1996 |
K961330 |
MEDICAL MARKETING CONCEPTS |
BAGRIGHT INFANT RESUSCITATOR |
07/02/1996 |
K961331 |
MEDICAL MARKETING CONCEPTS |
BAGRIGHT RESPOSABLE CHILD RESUSCITATOR |
06/28/1996 |
K961332 |
MEDICAL MARKETING CONCEPTS |
BAGRIGHT RESPOSABLE INFANT RESUSCITATOR |
06/28/1996 |
K961369 |
MEDICAL MARKETING CONCEPTS |
BAGRIGHT RESPOSABLE RESUSCITATOR |
06/28/1996 |
K953546 |
MEDICAL MARKETING CONCEPTS |
MANUAL PULMONARY RESUSICITATOR |
02/29/1996 |
K982215 |
MEDICAL MARKETING CONCEPTS |
MANUAL RESUSCITATOR WITH ACE |
09/18/1998 |
K961868 |
MEDICAL MARKETING CONCEPTS |
RESPOSABLE CHILD RESUSCITATOR |
06/28/1996 |
K961882 |
MEDICAL MARKETING CONCEPTS |
RESPOSABLE INFANT RESUSCITATOR |
06/28/1996 |
K954866 |
MERCURY MEDICAL |
MERCURY CPR (COMPLETE PERSONAL RESUSCIATOR) BAG WITH EXPANDABLE RESERVOIR |
01/30/1996 |
K970756 |
MERCURY MEDICAL |
MERCURY MEDICAL REUSABLE CPR BAG |
10/31/1997 |
K031395 |
MERLIN MEDICAL LIMITED |
MERLIN RESUSCITATOR |
07/16/2004 |
K093081 |
MICROBVM SYSTEMS LTD |
POCKET BVM |
02/05/2010 |
K973419 |
NELLCOR PURITAN BENNETT, INC. |
DMR PLUS DISPOSABLE MANUAL RESUSCITATOR |
03/25/1998 |
K960468 |
NELLCOR PURITAN BENNETT, INC. |
DMR/CO2 COMBO KTI |
04/26/1996 |
K023494 |
NELLCOR PURITAN BENNETT, INC. |
NELLCOR INDGO MANUAL RESUSCITATOR |
02/07/2003 |
K072021 |
NEOFORCE GROUP, INC. |
NEOPIP INFANT RESUSCITATOR |
09/12/2007 |
K102649 |
NEOFORCE GROUP, INC. |
NEOPOP INFANT RESUSCITATOR WITH FLOW METER |
01/06/2011 |
K021328 |
O-TWO SYSTEMS INTERNATIONAL INC. |
SMART BAG MO |
06/26/2003 |
K021446 |
OEMEDIC INTERNATIONAL, INC. |
OEMEDIC INTERNATIONAL INC. BESMED SILICONE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH MASK AND RESERVOIR |
10/11/2002 |
K021442 |
OEMEDIC INTERNATIONAL, INC. |
OEMEDIC INTERNATIONAL INC. BESMED SINGLE USE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH MASK & RESERVOIR |
07/30/2002 |
K070247 |
OHMEDA MEDICAL |
GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM |
04/20/2007 |
K971243 |
OHMEDA MEDICAL |
OHMEDA INFANT RESUSCITATION SYSTEM |
12/02/1997 |
K963848 |
OWENS-BRIGAM MEDICAL CO. |
MANUAL RESUSCITATOR |
07/07/1997 |
K980066 |
PLASCO, INC. |
CPR FILTERSHIELD |
07/16/1998 |
K021716 |
POLYMED (XIAMEN) PLASTIC INDUSTRIAL CO.,LTD. |
SIMPLIFY COMPACT RESUSCITATOR |
10/08/2002 |
K023793 |
PORTEX, INC. |
1ST RESPONSE INTERMEDIATE MANUAL RESUSCITATOR |
02/11/2003 |
K014115 |
PORTEX, INC. |
1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX |
02/27/2002 |
K970991 |
PROMEDIC, INC. |
DATEX ENGSTOM MANUAL RESUSCITATOR |
06/16/1997 |
K993194 |
RUSCH, INC. |
RUSCH MANUAL RESUSCITATOR BAG |
03/24/2000 |
K212905 |
Safe BVM Corporation |
Sotair Device |
08/18/2022 |
K974141 |
SCHIFF & CO. |
PLUS REUSABLE RESUSCITATOR |
05/21/1998 |
K972283 |
SIMS |
SIMS 1ST RESPONSE MANUAL RESUSCITATOR, ADULT |
09/17/1997 |
K991861 |
SIMS PORTEX, INC. |
1ST RESPONSE INFANT MANUAL RESUSCITATOR, BAG RESEVOIR, 1ST RESPONSE PEDIATRIC MANUAL RESUSCITATOR, BAG RESERVOIR, 1ST RE |
01/18/2000 |
K992057 |
SIMS PORTEX, INC. |
IST RESPONSE MANUAL RESUSCITATOR, MODELS, 008000, 008003,008006 |
09/13/1999 |
K032596 |
STURDY INDUSTRIAL CO., LTD |
STURDY MANUAL RESUSCITATOR |
08/05/2004 |
K030864 |
VEDI CORP. |
VADI MANUAL RESUSCITATOR |
01/30/2004 |
K012842 |
VENTLAB CORP. |
V*CARE MANUAL RESUSCITATOR |
09/18/2001 |
K210288 |
Xiamen Compower Medical Tech. Co., Ltd. |
Disposable Manual Resuscitator |
08/26/2021 |