FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K090317 |
A PLUS MEDICAL |
BABI*PLUS BUBBLE PAP VALVE |
05/20/2009 |
K110713 |
AIRWAYS DEVELOPMENT, LLC |
WATERPAP VALVE |
09/12/2011 |
K160112 |
BESMED HEALTH BUSINESS CORP. |
Besmed PEEP Valve |
04/29/2016 |
K982283 |
CARADYNE, LTD. |
WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 WHISPERFLOW OXYGEN FLOW GENERATOR - FIXED MODEL WF 8530 WH |
03/09/1999 |
K981415 |
CHEEN HOUNG ENT. CO. LTD. |
0-20 CM H20 PEEP VALVE |
07/14/1998 |
K092029 |
DRAEGER MEDICAL AG & CO. KG |
VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310 |
08/06/2010 |
K983920 |
ENGINEERED MEDICAL SYSTEMS |
EMS PEEP VALVES- ADJUSTABLE |
01/22/1999 |
K133957 |
GALEMED CORP. |
DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE |
04/14/2014 |
K963347 |
INSTRUMENTATION INDUSTRIES, INC. |
REUSABLE, ADJUSTABLE, MAGNETIC PEEP VALVE BE 142 |
03/19/1997 |
K050918 |
KOO AMERICAS, INC. |
KOO AMERICAS VALVE PEEP, MODEL KM-809 |
06/06/2005 |
K961867 |
MEDICAL MARKETING CONCEPTS |
PEEP VALVE |
08/13/1996 |
K081266 |
MERCURY ENTERPRIZES DBA MERCURY MEDICAL |
MERCURY MEDICAL PEEP VALVE |
03/05/2009 |
K090710 |
MERCURY MEDICAL |
MERCURY CPAP |
08/20/2009 |
K070416 |
NEOFORCE GROUP, INC. |
NEOPEEP NEONATAL RESUSCITATION CIRCUIT WITH PEEP |
05/29/2007 |
K103833 |
NEOFORCE GROUP, INC. |
NEOPIP PATIENT CIRCUIT WITH PEEP |
04/20/2011 |
K962492 |
NIDEK MEDICAL PRODUCTS, INC. |
SILENZIO PLUS CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM |
01/23/1997 |
K112546 |
O-TWO MEDICAL TECHNOLOGIES, INC. |
O_TWO CPAP SYSTEM |
12/27/2011 |
K080256 |
PULMODYNE |
PULMODYNE CHF FLOW GENERATOR SYSTEM |
05/09/2008 |
K133210 |
S & T MEDICAL TECHNOLOGIES, INC. |
B&B BUBBLER |
03/28/2014 |
K122610 |
SEN MU TECHNOLOGY CO., LTD. |
PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES |
08/05/2013 |
K001318 |
SIMS PORTEX, INC. |
CPAP SYSTEM, MODEL 102001 |
07/20/2000 |
K013884 |
VYGON S A |
BOUSSIGNAC C.P.A.P. DEVICE |
01/21/2003 |
K955047 |
WESTMED INTL. |
WESTMED CIRCULARIE PEP DEVICES |
03/27/1996 |