Plethysmograph, Impedance

FDA product code DSB · 111 cleared devices

Class 2 Cardiovascular

Regulation: 21 CFR 870.2770
Review panel: CV
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-11-18 – 2026-08-17

DSB 2026-08-17

MySOZO Software version 6.1.0.1 (SW version 6.1.0.1)

Applicant ImpediMed Limited

K number K260224

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DSB 2025-11-24

BCM2-Body Composition Monitor

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K number K250634

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DSB 2025-10-16

Re:Balans

Applicant Mode Sensors AS

K number K243727

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DSB 2025-09-09

Edema Guard Monitor (EGM) CardioSet-001

Applicant Cardioset Medical , Ltd.

K number K250922

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DSB 2023-10-17

SOZO Pro

Applicant ImpediMed Limited

K number K232089

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DSB 2023-06-16

Zynex Monitoring System, Model CM-1600

Applicant Zynex Medical, Inc.

K number K223217

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DSB 2022-07-29

Bodyport Cardiac Scale

Applicant Bodyport, Inc.

K number K211585

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DSB 2021-04-19

SOZO

Applicant ImpediMed Limited

K number K203473

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DSB 2020-10-02

SOZO Body Fluid Analyzer

Applicant ImpediMed Limited

K number K193410

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DSB 2020-02-21

Cardiac Monitor 1500

Applicant Zynex Medical, Inc.

K number K191697

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DSB 2019-02-28

ReDS System

Applicant Sensible Medical Innovations , Ltd.

K number K180479

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DSB 2018-03-14

Cardiovascular Analzyer

Applicant Physiowave, Inc.

K number K172431

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DSB 2017-12-22

SOZO

Applicant ImpediMed Limited

K number K172507

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DSB 2017-09-19

ECOM™ Cardiac Output Monitoring System

Applicant Ecom Medical, Inc.

K number K172196

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DSB 2013-12-20

ECOM ENDOTRACHEAL CARDIAC OUTPUT MONITOR SYSTEM

Applicant Conmed Corporation

K number K131765

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DSB 2013-06-28

ZOE FLUID STATUS MONITOR

Applicant Noninvasive Medical Technologies, Inc.

K number K131509

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DSB 2012-11-13

ZOEFLUID STATUS MONITOR (MODEL ZOE 2B)

Applicant Noninvasive Medical Technologies, Inc.

K number K112830

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DSB 2011-06-03

BIO Z CARDIO PROFILE HEMODYNAMIC MONITOR

Applicant Sonosite,Inc.

K number K110645

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DSB 2011-01-25

CHEETAH RELIANT

Applicant Cheetah Medical, Inc.

K number K103166

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DSB 2010-12-03

PHYSIOFLOW ENDURO

Applicant Vasocom, Inc.

K number K103283

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DSB 2009-06-18

BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM

Applicant N.I. Medical, Ltd.

K number K080941

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DSB 2009-05-28

CARDIODYNAMICS BIOZ RX, MODEL 7101-SYS

Applicant Cardiodynamics International Corp.

K number K090602

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DSB 2008-12-15

CHEETAH RELIANT

Applicant Cheetah Medical, Inc.

K number K083093

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DSB 2008-10-08

ICON, MODEL C3

Applicant Osypka Medical, Inc.

K number K082242

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DSB 2008-05-30

AESCULON C2, AESCULON CHF CLINIC C2, AESCULON HYPERTENSION CLINIC C2 AND AESCULON PACEMAKER CLINIC C2

Applicant Osypka Medical, Inc.

K number K081035

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DSB 2008-04-10

PHYSIOFLOW SYSTEM

Applicant Vasocom, Inc.

K number K060387

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DSB 2008-02-01

AESCULON CHF, HYPERTENSION & PACEMAKER CLINIC

Applicant Osypka Medical, Inc.

K number K070985

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DSB 2008-01-16

CHEETAH RELIANT, CHEETAH ACTIVE

Applicant Cheetah Medical, Inc.

K number K072662

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DSB 2007-09-26

BIOZ DX HEMODYNAMIC MONITOR WITH PHILIPS 12-LEAD ECG, MODEL 5100

Applicant Cardiodynamics International Corp.

K number K070156

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DSB 2007-07-16

BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM, MODEL NICAS 2004 SLIM

Applicant Ni Medical

K number K070500

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DSB 2005-06-10

BIOZDX HEMODYNAMIC MONITOR AND 12-LEAD ECG

Applicant Cardiodynamics International Corp.

K number K051228

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DSB 2004-12-08

BIOZDX HEMODYNAMIC MONITOR

Applicant Cardiodynamics International Corp.

K number K041294

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DSB 2004-09-14

ZOE FLUID STATUS MONITOR

Applicant Noninvasive Medical Technologies, LLC

K number K042113

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DSB 2004-08-06

C3 AND LIFEGARD ICG IMPEDANCE CARDIOGRAPHY MONITORS

Applicant Analogic Corp.

K number K041434

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DSB 2003-09-04

ECOM CV4 ENDOTRACHEAL CARDIAC OUTPUT MONITOR

Applicant Imagyn Medical Technologies, Inc.

K number K032491

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DSB 2003-04-29

ECOM ENDOTRACHIAL CARDIAC OUTPUT MONITOR

Applicant Imagyn Surgical

K number K021174

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DSB 2002-02-07

TASK FORCE MONITOR 3040

Applicant Cnsystems Medizintechnik GmbH

K number K014063

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DSB 2002-01-30

SORBA STEORRA NON-INVASIVE IMPEDANCE CARDIOGRAPH

Applicant Sorba Medical Systems, Inc.

K number K014299

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DSB 2001-11-02

MODIFICATION TO BIOZ.COM HEMODYNAMIC MONITOR

Applicant Cardiodynamics International Corp.

K number K011439

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DSB 2001-07-03

BIOZTECT SENSOR AND BIOZTECT CABLE

Applicant Cardiodynamics International Corp.

K number K011797

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DSB 2001-04-09

ICG MODULE

Applicant General Electric Medical Systems Information Techn

K number K010164

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DSB 2000-06-30

BIOZ.PC HEMODYNAMIC MONITOR MODEL BZ-500/BZ-501; BIOZ.PC USER SOFTWARE INSTALLATION KIT MODEL BZ-810

Applicant Cardiodynamics International Corp.

K number K001081

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DSB 2000-05-05

BIOZ.COM HEMODYNAMIC MONITOR WITH BIOZ TECT SENSOR AND BIOZ TECT CABLE IMPEDANCE PLETHYSMOGRAPH

Applicant Cardiodynamics International Corp.

K number K001100

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DSB 1999-02-08

IQ SYSTEM

Applicant Renaissance Technology, Inc.

K number K981720

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DSB 1998-03-18

BIOZ.COM SYSTEM

Applicant Cardiodynamics International Corp.

K number K974725

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DSB 1998-01-27

PERCUPUMP II WITH EDA

Applicant E-Z-Em, Inc.

K number K974621

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DSB 1997-10-23

EDEMA SYSTEM

Applicant Bioanalogics, Inc.

K number K962783

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DSB 1997-09-11

BIOZ SYSTEM & BIOZ PORTABLE

Applicant Cardiodynamics International Corp.

K number K972320

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DSB 1997-06-10

HOTMAN

Applicant Hemo Sapiens, Inc.

K number K952172

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DSB 1997-04-01

D SERIES ELECTRODE

Applicant Cmc Sense-It, Inc.

K number K970603

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DSB 1997-01-23

PERCUPUMP II WITH EDA

Applicant E-Z-Em, Inc.

K number K961845

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DSB 1996-11-26

BIOZ SYSTEM

Applicant Cardiodynamics International Corp.

K number K963183

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DSB 1996-06-28

NICAS 2001 NONINVASIVE CARDIO-RESPIRATORY SYSTEM

Applicant C.L. Mcintosh & Assoc., Inc.

K number K942227

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DSB 1995-12-28

FUTREX-5000A

Applicant Futrex, Inc.

K number K922601

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DSB 1995-12-28

FUTREX-5000

Applicant Futrex, Inc.

K number K922600

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DSB 1995-11-22

BODYSTAY

Applicant Bodystat , Ltd.

K number K951097

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DSB 1995-08-15

SORBA MODEL CIC-1000 NON-INVASIVE HEMODYNAMIC MONITOR

Applicant Sorba Medical Systems, Inc.

K number K950389

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DSB 1994-12-15

HYPERGRAPH

Applicant Dermed Diagnostics, Inc.

K number K941162

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DSB 1994-11-01

BODY FAT ANALYZER MODEL TBF-105

Applicant Tanita Corp. of America

K number K930599

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DSB 1993-12-03

MODEL IPM-1 IMPEDANCE PULSE MONITOR

Applicant Electro-Diagnostic Instruments

K number K932438

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DSB 1992-01-15

MODIFIED SEISMOCARDIOGRAPH

Applicant Seismed Instruments, Inc.

K number K910994

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DSB 1991-11-07

VASCUMAP MEDICAL AIR PLETHYSMOGRAPH

Applicant Carolina Medical Electronics

K number K914200

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DSB 1991-09-30

IMPEDANCE PHLEBOGRAPH/PHOTOPLETHYSMOGRAPH-DVT-2000

Applicant Rjl Systems, Inc.

K number K911194

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DSB 1991-03-07

BODY COMPOSITION ANALYZER

Applicant Body Composition Analog, Inc.

K number K904970

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DSB 1991-01-16

IPG-II MODULE

Applicant Life Sciences Manufacturing, Inc.

K number K903700

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DSB 1991-01-08

BIO-IMPEDANCE ANALYZER

Applicant Xitron Technologies, Inc.

K number K904109

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DSB 1990-07-26

EM-SCAN HP-2 PEDIATRIC BODY COMPOSITION ANALYZER

Applicant Em-Scan, Inc.

K number K902042

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DSB 1990-06-28

PACEMAKER PATIENT ADAPTOR MODULE (PPAM)

Applicant Bomed Medical Mfg., Ltd.

K number K900213

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DSB 1990-06-11

DYNATRON 330 BODY COMPOSITION ANALYZER

Applicant Dynatronics Laser Corp.

K number K900321

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DSB 1990-03-28

MODIFIED SEISMOCARDIOGRAPH

Applicant Seismed Instruments, Inc.

K number K900130

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DSB 1990-03-27

PORTABLE AIR PLETHYSMOGRAPH

Applicant Life Sciences Manufacturing, Inc.

K number K895588

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DSB 1990-01-18

PROCORD MD3500 VASCULAR DIAGNOSTIC SYSTEM

Applicant D. E. Hokanson, Inc.

K number K896034

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DSB 1989-10-30

SEISMOCARDIOGRAPH - SCG(TM) 1000 SERIES

Applicant Seismed Instruments, Inc.

K number K892323

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DSB 1989-10-27

HD-2200 PNEUMO-DOP VASCULAR TESTING SYSTEM

Applicant Koven and Assoc., Inc.

K number K894892

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DSB 1989-09-22

HOLTAIN BODY COMPOSITION ANALYSER

Applicant Seritex, Inc.

K number K891928

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DSB 1989-09-05

VERIPOID 50 BIO-ELECTRICAL IMPEDANCE METER

Applicant V.S.B.B. Technologies, Inc.

K number K893963

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DSB 1989-06-01

ADDITIONAL SOFTWARE TO CARDIODYNAMIC MONITOR

Applicant Bomed Medical Mfg., Ltd.

K number K890408

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DSB 1988-12-16

NAPARIMA BIORESISTANCE METER & BODY COMP. ANALYZER

Applicant Naparima, Inc.

K number K883919

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DSB 1988-12-13

DANNINGER TRIMCHECK(TM) PORTABLE & DESK TOP MODELS

Applicant Buckman Co., Inc.

K number K881841

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DSB 1988-11-17

BIODYNAMICS MODEL 200 BODY COMPOSITION ANALYZER

Applicant Biodynamics Corp.

K number K884033

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DSB 1988-10-14

AIR PLETHYSMOGRAPH MODEL APG-1000

Applicant Aci Medical, Inc.

K number K881291

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DSB 1988-09-26

VERIPOID 50 BIO-ELECTRICAL IMPEDANCE METER

Applicant Micro Medical, Ltd.

K number K881851

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DSB 1988-07-28

BIODYNAMICS MODEL BI-400 BODY COMPOSITION ANALYZER

Applicant Biodynamics Corp.

K number K881968

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DSB 1988-07-12

PERIPHERAL VASCULAR LABORATORY ASSISTANT MODEL 101

Applicant Sp Innovations, Inc.

K number K874938

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DSB 1988-06-15

BIOLOGICAL OHM METER, BES 200Z

Applicant Bioelectrical Sciences, Inc.

K number K880926

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DSB 1988-03-16

BIODYNAMICS MODEL BI-300 BODY COMPOSITION ANALYZER

Applicant Biodynamics Corp.

K number K874361

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DSB 1987-06-05

CONSULTANT BODY COMPOSITION ANALYZER

Applicant Body Composition Analog, Inc.

K number K871040

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DSB 1987-03-17

BODY WATCH BODY COMPOSITION ANALYZER MODEL 2010

Applicant Body Watch, Inc.

K number K863833

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DSB 1987-03-06

OMNI-TRAK

Applicant Invivo Research Labs, Inc.

K number K864889

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DSB 1987-02-03

MODIFIED MODEL BIA-103 BODY COMPOSITION ANALYZER

Applicant Rjl Systems, Inc.

K number K862383

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DSB 1987-01-05

1990A BIO-RESISTANCE BODY COMPOSITION ANALYZER

Applicant Valhalla Scientific

K number K861205

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DSB 1986-11-17

BILATERAL IMPEDANCE PLETHYSMOGRAPH, BIP(TM)

Applicant Electro-Diagnostic Instruments

K number K862714

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DSB 1986-09-02

HA-2 HUMAN BODY COMPOSITION ANALYZER

Applicant Dj Medical Instrument Corp. C/O Keller & Heckman

K number K860749

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DSB 1986-04-14

BOMED-CDM

Applicant Bomed Medical Mfr., Ltd.

K number K853706

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DSB 1985-10-11

IPG-300

Applicant Thornton Associates, Inc.

K number K852238

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DSB 1985-07-08

BODY ANALYSIS SYSTEM (DEEMED SE 87/09/18)

Applicant Medi-Sport Testing, Inc.

K number K851415

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DSB 1985-06-20

LIGHT REFLECTION RHEOGRAPHY

Applicant Hemodynamics, Inc.

K number K852378

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DSB 1984-02-10

CARDIAC WALL MOTION DEVICE

Applicant Intl. Medical, Inc.

K number K833728

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DSB 1984-01-26

RAYDEN MEDICAL MINI PULSE VOLUME RECORD

Applicant Burditt & Calkins-Siemens-Elema

K number K833155

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DSB 1983-09-12

BIOFLOW

Applicant Bomed Medical Mfr., Ltd.

K number K831422

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