FDA 510(k) Applications for Medical Device Product Code "DRY"
(Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass)

FDA 510(k) Number Applicant Device Name Decision Date
K972962 3M COMPANY 3M CDI BLOOD PARAMETER MONITORING SYSTEM 500 11/06/1997
K915255 3M COMPANY CDI(TM) 300, 400 & 100, MODIFICATION 01/15/1992
K915265 3M COMPANY CDI(TM) H/S CUVETTE, MODIFICATION 01/15/1992
K973472 3M HEALTH CARE 3M CDI H/S CUVETTES WITH HEPARON TREATMENT 12/08/1997
K980732 3M HEALTH CARE 3M CDI QUICK-CELLS WITH HEPARIN TREATMENT 05/15/1998
K931968 3M HEALTH CARE, LTD. CDI 100 EXTRACORPOREAL HEMATOCRIT/OXYGEN SATURATIO 11/10/1993
K852124 AMERICAN BENTLEY HEMATOCRIT-SATURATION MONITOR HSM-100 09/16/1985
K823359 BENTLEY LABORATORIES, INC. OXYGEN CONSUMPTION MONITOR #OCM-0100 01/05/1983
K862069 BIOMEDICAL SENSORS, INC. CARDIOMET 4000 GAS MONITORING SYSTEMS 07/18/1986
K871221 CARDIOVASCULAR DEVICES, INC. CDI(TM) EXTRACORPOREAL BLOOD GAS SYSTEM 300 06/05/1987
K831225 CARDIOVASCULAR DEVICES, INC. GAS-STAT MONITORING SYSTEM 05/27/1983
K862953 CLASSIC MEDICAL PRODUCTS, INC. CLASSIC RESTING SILVER-SILVERCHLORIDE ELECTRODE 08/25/1986
K843709 COBE LABORATORIES, INC. COBE SATURATION CELL 10/24/1984
K900682 CONTOUR ELECTRODES, INC. PHANTOM RADIOTRANSLUCENT ECG MONITORING ELECTRODE 07/31/1990
K861277 CRITICHEM, INC. CRITICHEM CONTINUOUS BLOOD GAS MONTITOR, CVGM-1000 06/02/1986
K854357 DIAMOND ELECTRO-TECH, INC. GEM-6, WITH COMPONENTS 01/08/1986
K871686 DIAMOND SENSOR SYSTEMS GEM-CRIT CHECK 06/18/1987
K001388 DIDECO DATA MASTER PERFUSION MONITORING SYSTEM 07/28/2000
K821159 G.D. SEARLE AND CO. IN-LINE OXYGEN MONITORING SYSTEM 05/25/1982
K874839 GISH BIOMEDICAL, INC. STAT-SAT 05/13/1988
K955379 INTERNATIONAL BIOPHYSICS CORP. IBC GAS CELL COMPONENTS (1/2, 3/8, 1/4) 05/14/1996
K955380 INTERNATIONAL BIOPHYSICS CORP. IBC QUICK CELL COMPONENT (1/2, 3/8, 1/4) 05/14/1996
K903729 LEAD-LOK, INC. GOLD GATORS 09/14/1990
K090147 MAQUET CARDIOPULMONARY AG BLOOD MONITORING UNIT, MODEL BMU 40 04/22/2009
K900459 MEDI-GLOBE CORP. APPLICARD (EKG) 07/31/1990
K941922 MEDTRONIC BIO-MEDICUS, INC. MEDSAT OXYGEN SATURATION SYSTEM 02/17/1995
K012743 MEDTRONIC PERFUSION SYSTEMS TRILLIUM TRI-OPTIC MEASUREMENT CELL, MODEL TMC 25T, TMC38 T, TMC 50T 09/14/2001
K910421 MEDTRONIC VASCULAR SATURATION/HEMATOCRIT MONITOR SYSTEM 10/15/1991
K133157 MEDTRONIC, INC. TRI-OPTIC MEASUREMENT CELL; WITH BALANCE BIOSURFACE, WITH CARMEDA BIOACTIVE SURFACE, WITH TRILLIUM BIOSURFACE, WITH 6 10/23/2014
K811391 OXIMETRIX, INC. OXIMETRIX ACCU SAT CPB 07/20/1981
K843538 POLYSTAN C/O VITALCOR, INC. PO 2 LYTRODE 10/18/1984
K881006 SHILEY, INC. STOCKERT-SHILEY BUBBLE MONITOR 23-23-01 05/24/1988
K103168 SORIN GROUP DEUTSCHLAND GMBH B-CARE5 (B-CARE5 SENSOR MODULE, VENOUS SENSOR, HOLDER FOR MEASURING HEAD) 01/06/2011
K071725 SPECTRUM MEDICAL LTD M2 MONITOR 07/11/2007
K072131 SPECTRUM MEDICAL LTD M3 MONITOR 08/17/2007
K091908 SPECTRUM MEDICAL LTD M3 MONITOR 07/10/2009
K173591 Spectrum Medical Ltd Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas 03/28/2018
K163657 Spectrum Medical Ltd Quantum Workstation 01/18/2017
K181923 Spectrum Medical Ltd Quantum Workstation 12.1 08/17/2018
K110957 SPECTRUM MEDICAL, LLP M4 MONITOR 05/31/2011
K062468 SPECTRUM MEDICAL, LLP SPECTRUM M2 MONITOR 09/13/2006
K123039 TERUMO CARDIOVASCULAR SYSTEMS CORP. CDI BLOOD PARAMETER MONITORING SYSTEM 500 11/20/2012
K133658 TERUMO CARDIOVASCULAR SYSTEMS CORP. CDI BLOOD PARAMETER MONITORING SYSTEM 500 07/25/2014


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