FDA 510(k) Applications for Medical Device Product Code "BYE"
(Attachment, Breathing, Positive End Expiratory Pressure)
| 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 |
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