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BYT — Ventilator, External Body, Negative Pressure, Adult (Cuirass) Class II

FDA Device Classification

Classification Details

Product Code
BYT
Device Class
Class II
Regulation Number
868.5935
Submission Type
Review Panel
AN
Medical Specialty
Anesthesiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K082657medivent limitedRTX RESPIRATOROctober 8, 2008
K072290dima italiaPEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUSMay 29, 2008
K924341respironicsHAYEK OSCILLATOR(TM)July 21, 1993
K910947lifecare servicesNEV-10 NEGATIVE PRESSURE VENTILATORJune 3, 1991
K905530puritan bennettPURITAN-BENNETT COMPANION 500 LIQUID OXYGEN SYSTEMMarch 1, 1991
K902764j. h. emersonEMERSON 33-AN NEGATIVE PRESSURE RESPIRATOR ALARMNovember 19, 1990
K903745flexco medical instrumentsTHE HAYEK OSCILLATORNovember 9, 1990
K902300progressive productionsEASY BREATHER MODEL 100 ACCESSORIESJuly 19, 1990
K895849respironicsRESPIRONICS VACUVEST RESPIRATORY SUPPORT SYSTEMDecember 22, 1989
K894649emerson intlEMERSON 33-CR CHEST RESPIRATOROctober 13, 1989
K893213progressive productionsEASY BREATHER MODEL 100August 4, 1989
K881808j. h. emersonEMERSON CHEST RESPIRATOR, MODEL 33-CREAugust 4, 1988
K881689lindley resuscitatorLINDLEY II RESUSCITATORJuly 8, 1988
K863300quintonQ101 DIAGNOSTIC SPIROMETERNovember 13, 1986
K860692bear medical systemsPTR MK II VENTILATORMay 21, 1986
K840885edwards ventilatorLAKEVILLE BODY VENTILATORJuly 12, 1984
K841090porta-lungVENTILATOR EXTERNAL BODY NEGATIVE PRESSMay 30, 1984
K832176j. h. emersonNEGATIVE PRESSURE CHEST RESPIRATOR PUMPSeptember 12, 1983
K813326l.t.d. 3TROCKI BODY VENTRILATORDecember 22, 1981
K792673lifecare servicesCAM-10 CUIRASS SHELLJanuary 11, 1980