FDA 510(k) Applications for Medical Device Product Code "DSB"
(Plethysmograph, Impedance)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K041434 | ANALOGIC CORP. | C3 AND LIFEGARD ICG IMPEDANCE CARDIOGRAPHY MONITORS | 08/06/2004 |
| K962783 | BIOANALOGICS, INC. | EDEMA SYSTEM | 10/23/1997 |
| K211585 | Bodyport Inc. | Bodyport Cardiac Scale | 07/29/2022 |
| K942227 | C.L. MCINTOSH & ASSOC., INC. | NICAS 2001 NONINVASIVE CARDIO-RESPIRATORY SYSTEM | 06/28/1996 |
| 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 |
| 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 |
| 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 |
| K010164 | GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN | ICG MODULE | 04/09/2001 |
| K952172 | HEMO SAPIENS, INC. | HOTMAN | 06/10/1997 |
| 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 |
| K203473 | ImpediMed Limited | SOZO | 04/19/2021 |
| K193410 | ImpediMed Limited | SOZO Body Fluid Analyzer | 10/02/2020 |
| K142503 | INTERSECTION MEDICAL, INC. | IMED-Z FLUID STATUS MONITOR | 06/05/2015 |
| K080941 | N.I. MEDICAL, LTD. | BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM | 06/18/2009 |
| 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 |
| K180479 | Sensible Medical Innovations Ltd. | ReDS System | 02/28/2019 |
| K150095 | SENSIBLE MEDICAL INNOVATIONS LTD. | ReDs Wearable System | 08/06/2015 |
| K110645 | SONOSITE,INC. | BIO Z CARDIO PROFILE HEMODYNAMIC MONITOR | 06/03/2011 |
| K014299 | SORBA MEDICAL SYSTEMS, INC. | SORBA STEORRA NON-INVASIVE IMPEDANCE CARDIOGRAPH | 01/30/2002 |
| 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 |
| K191697 | Zynex Medical, Inc. | Cardiac Monitor 1500 | 02/21/2020 |
| K223217 | Zynex Medical, Inc. | Zynex Monitoring System, Model CM-1600 | 06/16/2023 |
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