Home / Device Classification / BYE

BYE — Attachment, Breathing, Positive End Expiratory Pressure Class II

FDA Device Classification

Classification Details

Product Code
BYE
Device Class
Class II
Regulation Number
868.5965
Submission Type
Review Panel
AN
Medical Specialty
Anesthesiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K160112besmed health businessBesmed PEEP ValveApril 29, 2016
K133957galemedDISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USEApril 14, 2014
K133210s and t medical technologiesB&B BUBBLERMarch 28, 2014
K122610sen mu technology coPLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIESAugust 5, 2013
K112546o-two medical technologiesO_TWO CPAP SYSTEMDecember 27, 2011
K110713airways developmentWATERPAP VALVESeptember 12, 2011
K103833neoforce groupNEOPIP PATIENT CIRCUIT WITH PEEPApril 20, 2011
K092029draeger medical ag and co. kgVENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310August 6, 2010
K090710mercury medicalMERCURY CPAPAugust 20, 2009
K090317a plus medicalBABI*PLUS BUBBLE PAP VALVEMay 20, 2009
K081266mercury enterprizes dba mercury medicalMERCURY MEDICAL PEEP VALVEMarch 5, 2009
K080256pulmodynePULMODYNE CHF FLOW GENERATOR SYSTEMMay 9, 2008
K070416neoforce groupNEOPEEP NEONATAL RESUSCITATION CIRCUIT WITH PEEPMay 29, 2007
K050918koo americasKOO AMERICAS VALVE PEEP, MODEL KM-809June 6, 2005
K013884vygonBOUSSIGNAC C.P.A.P. DEVICEJanuary 21, 2003
K001318sims portexCPAP SYSTEM, MODEL 102001July 20, 2000
K982283caradyneWHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 WHISPERFLOW OXYGEN March 9, 1999
K983920engineered medical systemsEMS PEEP VALVES- ADJUSTABLEJanuary 22, 1999
K981415cheen houng ent. co.0-20 CM H20 PEEP VALVEJuly 14, 1998
K963347instrumentation industriesREUSABLE, ADJUSTABLE, MAGNETIC PEEP VALVE BE 142March 19, 1997