FDA 510(k) Applications for Medical Device Product Code "BYT"
(Ventilator, External Body, Negative Pressure, Adult (Cuirass))

FDA 510(k) Number Applicant Device Name Decision Date
K860692 BEAR MEDICAL SYSTEMS, INC. PTR MK II VENTILATOR 05/21/1986
K072290 DIMA ITALIA SRL PEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUS 05/29/2008
K840885 EDWARDS VENTILATOR CO. LAKEVILLE BODY VENTILATOR 07/12/1984
K894649 EMERSON INTL. CO. EMERSON 33-CR CHEST RESPIRATOR 10/13/1989
K903745 FLEXCO MEDICAL INSTRUMENTS THE HAYEK OSCILLATOR 11/09/1990
K902764 J. H. EMERSON CO. EMERSON 33-AN NEGATIVE PRESSURE RESPIRATOR ALARM 11/19/1990
K881808 J. H. EMERSON CO. EMERSON CHEST RESPIRATOR, MODEL 33-CRE 08/04/1988
K832176 J. H. EMERSON CO. NEGATIVE PRESSURE CHEST RESPIRATOR PUMP 09/12/1983
K813326 L.T.D. 3 CO. TROCKI BODY VENTRILATOR 12/22/1981
K791406 LIFECARE SERVICES, INC. CAM-10 CHEST SHELL 08/10/1979
K792673 LIFECARE SERVICES, INC. CAM-10 CUIRASS SHELL 01/11/1980
K910947 LIFECARE SERVICES, INC. NEV-10 NEGATIVE PRESSURE VENTILATOR 06/03/1991
K881689 LINDLEY RESUSCITATOR, INC. LINDLEY II RESUSCITATOR 07/08/1988
K082657 MEDIVENT LIMITED RTX RESPIRATOR 10/08/2008
K841090 PORTA-LUNG CO. VENTILATOR EXTERNAL BODY NEGATIVE PRESS 05/30/1984
K893213 PROGRESSIVE PRODUCTIONS LTD. EASY BREATHER MODEL 100 08/04/1989
K902300 PROGRESSIVE PRODUCTIONS LTD. EASY BREATHER MODEL 100 ACCESSORIES 07/19/1990
K905530 PURITAN BENNETT CORP. PURITAN-BENNETT COMPANION 500 LIQUID OXYGEN SYSTEM 03/01/1991
K863300 QUINTON, INC. Q101 DIAGNOSTIC SPIROMETER 11/13/1986
K924341 RESPIRONICS, INC. HAYEK OSCILLATOR(TM) 07/21/1993
K895849 RESPIRONICS, INC. RESPIRONICS VACUVEST RESPIRATORY SUPPORT SYSTEM 12/22/1989


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