FDA 510(k) Applications for Medical Device Product Code "DSB"
(Plethysmograph, Impedance)

FDA 510(k) Number Applicant Device Name Decision Date
K881291 ACI MEDICAL, INC. AIR PLETHYSMOGRAPH MODEL APG-1000 10/14/1988
K041434 ANALOGIC CORP. C3 AND LIFEGARD ICG IMPEDANCE CARDIOGRAPHY MONITORS 08/06/2004
K962783 BIOANALOGICS, INC. EDEMA SYSTEM 10/23/1997
K884033 BIODYNAMICS CORP. BIODYNAMICS MODEL 200 BODY COMPOSITION ANALYZER 11/17/1988
K874361 BIODYNAMICS CORP. BIODYNAMICS MODEL BI-300 BODY COMPOSITION ANALYZER 03/16/1988
K881968 BIODYNAMICS CORP. BIODYNAMICS MODEL BI-400 BODY COMPOSITION ANALYZER 07/28/1988
K880926 BIOELECTRICAL SCIENCES, INC. BIOLOGICAL OHM METER, BES 200Z 06/15/1988
K820959 BIOFAX MEDICAL INSTRUMENTATION CO. BLOOD FLOW ANALYZER 05/25/1982
K904970 BODY COMPOSITION ANALOG, INC. BODY COMPOSITION ANALYZER 03/07/1991
K871040 BODY COMPOSITION ANALOG, INC. CONSULTANT BODY COMPOSITION ANALYZER 06/05/1987
K863833 BODY WATCH, INC. BODY WATCH BODY COMPOSITION ANALYZER MODEL 2010 03/17/1987
K951097 BODYSTAT LTD. BODYSTAY 11/22/1995
K890408 BOMED MEDICAL MFG., LTD. ADDITIONAL SOFTWARE TO CARDIODYNAMIC MONITOR 06/01/1989
K900213 BOMED MEDICAL MFG., LTD. PACEMAKER PATIENT ADAPTOR MODULE (PPAM) 06/28/1990
K831422 BOMED MEDICAL MFR., LTD. BIOFLOW 09/12/1983
K811999 BOMED MEDICAL MFR., LTD. BO MED BIA 08/31/1981
K831421 BOMED MEDICAL MFR., LTD. BOMED BIOCON 09/12/1983
K853706 BOMED MEDICAL MFR., LTD. BOMED-CDM 04/14/1986
K881841 BUCKMAN CO., INC. DANNINGER TRIMCHECK(TM) PORTABLE & DESK TOP MODELS 12/13/1988
K833155 BURDITT & CALKINS-SIEMENS-ELEMA RAYDEN MEDICAL MINI PULSE VOLUME RECORD 01/26/1984
K942227 C.L. MCINTOSH & ASSOC., INC. NICAS 2001 NONINVASIVE CARDIO-RESPIRATORY SYSTEM 06/28/1996
K822020 CARDIO KINETICS, INC. CKG 8000 08/06/1982
K070156 CARDIODYNAMICS INTERNATIONAL CORP. BIOZ DX HEMODYNAMIC MONITOR WITH PHILIPS 12-LEAD ECG, MODEL 5100 09/26/2007
K963183 CARDIODYNAMICS INTERNATIONAL CORP. BIOZ SYSTEM 11/26/1996
K972320 CARDIODYNAMICS INTERNATIONAL CORP. BIOZ SYSTEM & BIOZ PORTABLE 09/11/1997
K001100 CARDIODYNAMICS INTERNATIONAL CORP. BIOZ.COM HEMODYNAMIC MONITOR WITH BIOZ TECT SENSOR AND BIOZ TECT CABLE IMPEDANCE PLETHYSMOGRAPH 05/05/2000
K974725 CARDIODYNAMICS INTERNATIONAL CORP. BIOZ.COM SYSTEM 03/18/1998
K001081 CARDIODYNAMICS INTERNATIONAL CORP. BIOZ.PC HEMODYNAMIC MONITOR MODEL BZ-500/BZ-501; BIOZ.PC USER SOFTWARE INSTALLATION KIT MODEL BZ-810 06/30/2000
K041294 CARDIODYNAMICS INTERNATIONAL CORP. BIOZDX HEMODYNAMIC MONITOR 12/08/2004
K051228 CARDIODYNAMICS INTERNATIONAL CORP. BIOZDX HEMODYNAMIC MONITOR AND 12-LEAD ECG 06/10/2005
K011797 CARDIODYNAMICS INTERNATIONAL CORP. BIOZTECT SENSOR AND BIOZTECT CABLE 07/03/2001
K090602 CARDIODYNAMICS INTERNATIONAL CORP. CARDIODYNAMICS BIOZ RX, MODEL 7101-SYS 05/28/2009
K011439 CARDIODYNAMICS INTERNATIONAL CORP. MODIFICATION TO BIOZ.COM HEMODYNAMIC MONITOR 11/02/2001
K823215 CARDIOKINETICS, INC. CKG 8800 11/24/1982
K792051 CARDIOKINETICS, INC. CKG CARDIOKYMOGRAPH 11/13/1979
K914200 CAROLINA MEDICAL ELECTRONICS VASCUMAP MEDICAL AIR PLETHYSMOGRAPH 11/07/1991
K083093 CHEETAH MEDICAL INC. CHEETAH RELIANT 12/15/2008
K103166 CHEETAH MEDICAL INC. CHEETAH RELIANT 01/25/2011
K072662 CHEETAH MEDICAL INC. CHEETAH RELIANT, CHEETAH ACTIVE 01/16/2008
K970603 CMC SENSE-IT, INC. D SERIES ELECTRODE 04/01/1997
K014063 CNSYSTEMS MEDIZINTECHNIK GMBH TASK FORCE MONITOR 3040 02/07/2002
K131765 CONMED CORPORATION ECOM ENDOTRACHEAL CARDIAC OUTPUT MONITOR SYSTEM 12/20/2013
K896034 D. E. HOKANSON, INC. PROCORD MD3500 VASCULAR DIAGNOSTIC SYSTEM 01/18/1990
K941162 DERMED DIAGNOSTICS, INC. HYPERGRAPH 12/15/1994
K860749 DJ MEDICAL INSTRUMENT CORP. C/O KELLER & HECKMAN HA-2 HUMAN BODY COMPOSITION ANALYZER 09/02/1986
K772092 DYNATECH RESEARCH & DEVELOPMENT CO. CHEST FLUID MONITOR 11/18/1977
K900321 DYNATRONICS LASER CORP. DYNATRON 330 BODY COMPOSITION ANALYZER 06/11/1990
K961845 E-Z-EM, INC. PERCUPUMP II WITH EDA 01/23/1997
K974621 E-Z-EM, INC. PERCUPUMP II WITH EDA 01/27/1998
K172196 ECOM Medical, Inc ECOMÖ Cardiac Output Monitoring System 09/19/2017
K862714 ELECTRO-DIAGNOSTIC INSTRUMENTS BILATERAL IMPEDANCE PLETHYSMOGRAPH, BIP(TM) 11/17/1986
K932438 ELECTRO-DIAGNOSTIC INSTRUMENTS MODEL IPM-1 IMPEDANCE PULSE MONITOR 12/03/1993
K822455 ELECTRO-DIAGNOSTIC INSTRUMENTS VASOGRAPH, MODEL MV-2 09/24/1982
K902042 EM-SCAN, INC. EM-SCAN HP-2 PEDIATRIC BODY COMPOSITION ANALYZER 07/26/1990
K922600 FUTREX, INC. FUTREX-5000 12/28/1995
K922601 FUTREX, INC. FUTREX-5000A 12/28/1995
K010164 GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN ICG MODULE 04/09/2001
K952172 HEMO SAPIENS, INC. HOTMAN 06/10/1997
K852378 HEMODYNAMICS, INC. LIGHT REFLECTION RHEOGRAPHY 06/20/1985
K032491 IMAGYN MEDICAL TECHNOLOGIES, INC. ECOM CV4 ENDOTRACHEAL CARDIAC OUTPUT MONITOR 09/04/2003
K021174 IMAGYN SURGICAL ECOM ENDOTRACHIAL CARDIAC OUTPUT MONITOR 04/29/2003
K172507 ImpediMed Limited SOZO 12/22/2017
K142503 INTERSECTION MEDICAL, INC. IMED-Z FLUID STATUS MONITOR 06/05/2015
K833728 INTL. MEDICAL, INC. CARDIAC WALL MOTION DEVICE 02/10/1984
K864889 INVIVO RESEARCH LABS, INC. OMNI-TRAK 03/06/1987
K894892 KOVEN AND ASSOC., INC. HD-2200 PNEUMO-DOP VASCULAR TESTING SYSTEM 10/27/1989
K822522 LIFE SCIENCES MANUFACTURING, INC. CUTANEOUS PRESSURE PLETHYSMOGRAPH 09/28/1982
K903700 LIFE SCIENCES MANUFACTURING, INC. IPG-II MODULE 01/16/1991
K895588 LIFE SCIENCES MANUFACTURING, INC. PORTABLE AIR PLETHYSMOGRAPH 03/27/1990
K851415 MEDI-SPORT TESTING, INC. BODY ANALYSIS SYSTEM (DEEMED SE 87/09/18) 07/08/1985
K781352 MEDIMATIC STRAIN GAUGE PLETHYSMOGRAPH 10/27/1978
K881851 MICRO MEDICAL, LTD. VERIPOID 50 BIO-ELECTRICAL IMPEDANCE METER 09/26/1988
K080941 N.I. MEDICAL, LTD. BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM 06/18/2009
K883919 NAPARIMA, INC. NAPARIMA BIORESISTANCE METER & BODY COMP. ANALYZER 12/16/1988
K070500 NI MEDICAL BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM, MODEL NICAS 2004 SLIM 07/16/2007
K133301 NONINVASIVE MEDICAL TECHNOLOGIES, INC. ZOE FLUID STATUS MONITOR 01/22/2014
K131509 NONINVASIVE MEDICAL TECHNOLOGIES, INC. ZOE FLUID STATUS MONITOR 06/28/2013
K112830 NONINVASIVE MEDICAL TECHNOLOGIES, INC. ZOEFLUID STATUS MONITOR (MODEL ZOE 2B) 11/13/2012
K042113 NONINVASIVE MEDICAL TECHNOLOGIES, LLC. ZOE FLUID STATUS MONITOR 09/14/2004
K081035 OSYPKA MEDICAL, INC. AESCULON C2, AESCULON CHF CLINIC C2, AESCULON HYPERTENSION CLINIC C2 AND AESCULON PACEMAKER CLINIC C2 05/30/2008
K070985 OSYPKA MEDICAL, INC. AESCULON CHF, HYPERTENSION & PACEMAKER CLINIC 02/01/2008
K082242 OSYPKA MEDICAL, INC. ICON, MODEL C3 10/08/2008
K172431 PhysioWave, Inc. Cardiovascular Analzyer 03/14/2018
K981720 RENAISSANCE TECHNOLOGY, INC. IQ SYSTEM 02/08/1999
K830292 RJL SYSTEMS, INC. BIOELECTRICAL IMPEDANCE ANALYZER #101 08/12/1983
K911194 RJL SYSTEMS, INC. IMPEDANCE PHLEBOGRAPH/PHOTOPLETHYSMOGRAPH-DVT-2000 09/30/1991
K862383 RJL SYSTEMS, INC. MODIFIED MODEL BIA-103 BODY COMPOSITION ANALYZER 02/03/1987
K910994 SEISMED INSTRUMENTS, INC. MODIFIED SEISMOCARDIOGRAPH 01/15/1992
K900130 SEISMED INSTRUMENTS, INC. MODIFIED SEISMOCARDIOGRAPH 03/28/1990
K892323 SEISMED INSTRUMENTS, INC. SEISMOCARDIOGRAPH - SCG(TM) 1000 SERIES 10/30/1989
K150095 SENSIBLE MEDICAL INNOVATIONS LTD. ReDs Wearable System 08/06/2015
K891928 SERITEX, INC. HOLTAIN BODY COMPOSITION ANALYSER 09/22/1989
K110645 SONOSITE,INC. BIO Z CARDIO PROFILE HEMODYNAMIC MONITOR 06/03/2011
K950389 SORBA MEDICAL SYSTEMS, INC. SORBA MODEL CIC-1000 NON-INVASIVE HEMODYNAMIC MONITOR 08/15/1995
K014299 SORBA MEDICAL SYSTEMS, INC. SORBA STEORRA NON-INVASIVE IMPEDANCE CARDIOGRAPH 01/30/2002
K874938 SP INNOVATIONS, INC. PERIPHERAL VASCULAR LABORATORY ASSISTANT MODEL 101 07/12/1988
K930599 TANITA CORP. OF AMERICA BODY FAT ANALYZER MODEL TBF-105 11/01/1994
K852238 THORNTON ASSOCIATES, INC. IPG-300 10/11/1985
K893963 V.S.B.B. TECHNOLOGIES, INC. VERIPOID 50 BIO-ELECTRICAL IMPEDANCE METER 09/05/1989
K861205 VALHALLA SCIENTIFIC 1990A BIO-RESISTANCE BODY COMPOSITION ANALYZER 01/05/1987
K103283 VASOCOM, INC. PHYSIOFLOW ENDURO 12/03/2010
K140102 VASOCOM, INC. PHYSIOFLOW Q-LINK 02/12/2014
K060387 VASOCOM, INC. PHYSIOFLOW SYSTEM 04/10/2008
K904109 XITRON TECHNOLOGIES, INC. BIO-IMPEDANCE ANALYZER 01/08/1991


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