FDA 510(k) Applications for Medical Device Product Code "DRM"
(Compressor, Cardiac, External)

FDA 510(k) Number Applicant Device Name Decision Date
K790513 BDT ENT. HLA-2000 05/31/1979
K801946 CARDIA CONCEPTS CORP. CPR HELPER 11/19/1980
K801947 CARDIA CONCEPTS CORP. CPR TRAVELER 11/19/1980
K801945 CARDIA CONCEPTS CORP. SAVE MOR 11/19/1980
K855004 D.A. SCHULMAN, INC. SWELL-RELIEF 02/12/1986
K141809 DEFIBTECH, LLC RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEM 10/27/2014
K951124 EEE MEDICAL ENT. CAD-2000 CARDIAC ASSIST DEVICE 11/20/1995
K024215 ENERTRON ENGINEERING CO. ENERTRON CPR JACK 05/14/2004
K841275 GYNECO, INC. FINE NEEDLE ASPIRATION DEVICE 08/17/1984
K922093 HASKEL, INC. HASKEL CPR 03/14/1994
K871272 HUNTLEIGH TECHNOLOGY, INC. HUNTLEIGH FLOWPAC FP2000 06/25/1987
K871271 HUNTLEIGH TECHNOLOGY, INC. HUNTLEIGH FLOWPRESS AC300 PUMP, SQ301/302/320 GAR. 09/15/1987
K053403 JOLIFE AB LUCAS 02/01/2006
K090422 JOLIFE AB LUCAS 2 06/17/2009
K173553 Jolife AB LUCAS 3 Chest Compression System 02/08/2018
K161768 Jolife AB LUCAS 3 Chest Compression System 11/09/2016
K062401 JOLIFE AB MODIFICATION TO LUCAS 09/28/2006
K841822 KEYMED, INC. KEYMED SIGMOIDOSCOPE SUCTION UNIT 07/27/1984
K761194 MCKESSON CORP. HLR QUICK-FIT HEART-LUNG RESUSCITATOR 12/09/1976
K854734 MEDASONICS, INC. MODEL 5320 TED SEQUENTIAL COMP. DE. COMP. LIMB SLE 02/10/1986
K062119 MEDICAL PRODUCTS MFG., LLC HLR MODEL 601 HEART LUNG RESUSCITATOR AND HEARTSAVER 100 09/22/2006
K833879 MICHIGAN INSTRUMENTS, INC. CARDIOPULMONARY RESUSCITATOR 12/27/1983
K811909 MICHIGAN INSTRUMENTS, INC. CARDIOPULMUNARY RESUSCITATOR 07/16/1981
K972525 MICHIGAN INSTRUMENTS, INC. THUMPER 10/02/1997
K962237 MICHIGAN INSTRUMENTS, INC. THUMPER CARDIOPULMONARY RESUSCITATOR 09/05/1996
K851139 MICHIGAN INSTRUMENTS, INC. THUMPER CARDIOPULMONARY RESUSCITATOR 1005 05/15/1985
K073079 MICHIGAN INSTRUMENTS, INC. THUMPER, MODEL: 1008 02/14/2008
K811987 OXEQUIP HEALTH IND. OXY-QUIK MARK IV OXYGEN INHALATOR 07/27/1981
K791145 PEPIN DISTRIBUTING, INC. CPR CONTROL SYSTEM 07/10/1979
K792454 PNEU PAC, LTD. PNEUPAC RESUSCITATOR INSTANT ACTION SET 02/05/1980
K792451 PNEU PAC, LTD. PNEUPAC RESUSCITATOR INSTANT ACTION SET 02/05/1980
K792452 PNEU PAC, LTD. PNEUPAC RESUSCITATOR INSTANT ACTION SET 02/05/1980
K792458 PNEU PAC, LTD. PNEUPAC TEST SET, PT.#500-A250 02/05/1980
K102068 RESUSCITATION INTERNATIONAL MINIATURIZE CHEST COMPRESSOR (MCC) 11/16/2010
K153628 Resuscitation International, LLC ROSC-U Mini Chest Compressor (RMCC) 01/30/2016
K022345 REVIVANT CORP. AUTOPULSE RESUSCITATION SYSTEM 08/15/2002
K040453 REVIVANT CORP. AUTOPULSE RESUSCITATION SYSTEM, MODEL 100 03/11/2004
K011046 REVIVANT CORP. AUTOPULSE, MODEL 100 10/25/2001
K032852 REVIVANT CORP. MODIFICATION TO: AUTOPULSE RESUSCITATION SYSTEM MODEL 100 11/12/2003
K841410 WARNE SURGICAL PRODUCTS, LTD. BUSH NECK W/TAP 04/18/1984
K063602 ZOLL CIRCULATION AUTOPULSE RESUSCITATION SYSTEM MODEL100 12/21/2006
K112998 ZOLL CIRCULATION AUTOPULSE RESUSCITATION SYSTEM MODEL 1000 03/15/2012
K072527 ZOLL CIRCULATION AUTOPULSE RESUSCITATION SYSTEM, MODEL 100 03/19/2008


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