FDA Product Code
FDA Product Code DSB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.2770
510(k) Clearances — 115 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260224 | MySOZO Software version 6.1.0.1 (SW version 6.1.0.1) | ImpediMed Limited | 2026-08-17 | Traditional | PDF ↗ |
| K250634 | BCM2-Body Composition Monitor | Fresenius Medical Care Renal Therapies Group, LLC | 2025-11-24 | Traditional | PDF ↗ |
| K243727 | Re:Balans | Mode Sensors AS | 2025-10-16 | Traditional | PDF ↗ |
| K250922 | Edema Guard Monitor (EGM) CardioSet-001 | Cardioset Medical , Ltd. | 2025-09-09 | Traditional | PDF ↗ |
| K232089 | SOZO Pro | ImpediMed Limited | 2023-10-17 | Traditional | PDF ↗ |
| K223217 | Zynex Monitoring System, Model CM-1600 | Zynex Medical, Inc. | 2023-06-16 | Traditional | PDF ↗ |
| K211585 | Bodyport Cardiac Scale | Bodyport, Inc. | 2022-07-29 | Traditional | PDF ↗ |
| K203473 | SOZO | ImpediMed Limited | 2021-04-19 | Traditional | PDF ↗ |
| K193410 | SOZO Body Fluid Analyzer | ImpediMed Limited | 2020-10-02 | Traditional | PDF ↗ |
| K191697 | Cardiac Monitor 1500 | Zynex Medical, Inc. | 2020-02-21 | Traditional | PDF ↗ |
| K180479 | ReDS System | Sensible Medical Innovations , Ltd. | 2019-02-28 | Traditional | PDF ↗ |
| K172431 | Cardiovascular Analzyer | Physiowave, Inc. | 2018-03-14 | Traditional | PDF ↗ |
| K172507 | SOZO | ImpediMed Limited | 2017-12-22 | Traditional | PDF ↗ |
| K172196 | ECOM Cardiac Output Monitoring System | Ecom Medical, Inc. | 2017-09-19 | Traditional | PDF ↗ |
| K150095 | ReDs Wearable System | Sensible Medical Innovations , Ltd. | 2015-08-06 | Traditional | PDF ↗ |
| K142503 | IMED-Z FLUID STATUS MONITOR | Intersection Medical, Inc. | 2015-06-05 | Traditional | PDF ↗ |
| K140102 | PHYSIOFLOW Q-LINK | Vasocom, Inc. | 2014-02-12 | Special | PDF ↗ |
| K133301 | ZOE FLUID STATUS MONITOR | Noninvasive Medical Technologies, Inc. | 2014-01-22 | Special | PDF ↗ |
| K131765 | ECOM ENDOTRACHEAL CARDIAC OUTPUT MONITOR SYSTEM | Conmed Corporation | 2013-12-20 | Traditional | PDF ↗ |
| K131509 | ZOE FLUID STATUS MONITOR | Noninvasive Medical Technologies, Inc. | 2013-06-28 | Special | PDF ↗ |
| K112830 | ZOEFLUID STATUS MONITOR (MODEL ZOE 2B) | Noninvasive Medical Technologies, Inc. | 2012-11-13 | Traditional | PDF ↗ |
| K110645 | BIO Z CARDIO PROFILE HEMODYNAMIC MONITOR | Sonosite,Inc. | 2011-06-03 | Traditional | PDF ↗ |
| K103166 | CHEETAH RELIANT | Cheetah Medical, Inc. | 2011-01-25 | Abbreviated | PDF ↗ |
| K103283 | PHYSIOFLOW ENDURO | Vasocom, Inc. | 2010-12-03 | Special | PDF ↗ |
| K080941 | BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM | N.I. Medical, Ltd. | 2009-06-18 | Traditional | PDF ↗ |
| K090602 | CARDIODYNAMICS BIOZ RX, MODEL 7101-SYS | Cardiodynamics International Corp. | 2009-05-28 | Traditional | PDF ↗ |
| K083093 | CHEETAH RELIANT | Cheetah Medical, Inc. | 2008-12-15 | Abbreviated | PDF ↗ |
| K082242 | ICON, MODEL C3 | Osypka Medical, Inc. | 2008-10-08 | Special | PDF ↗ |
| K081035 | AESCULON C2, AESCULON CHF CLINIC C2, AESCULON HYPERTENSION CLINIC C2 AND AESCULON PACEMAKER CLINIC C2 | Osypka Medical, Inc. | 2008-05-30 | Special | PDF ↗ |
| K060387 | PHYSIOFLOW SYSTEM | Vasocom, Inc. | 2008-04-10 | Traditional | PDF ↗ |
| K070985 | AESCULON CHF, HYPERTENSION & PACEMAKER CLINIC | Osypka Medical, Inc. | 2008-02-01 | Traditional | PDF ↗ |
| K072662 | CHEETAH RELIANT, CHEETAH ACTIVE | Cheetah Medical, Inc. | 2008-01-16 | Traditional | PDF ↗ |
| K070156 | BIOZ DX HEMODYNAMIC MONITOR WITH PHILIPS 12-LEAD ECG, MODEL 5100 | Cardiodynamics International Corp. | 2007-09-26 | Traditional | PDF ↗ |
| K070500 | BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM, MODEL NICAS 2004 SLIM | Ni Medical | 2007-07-16 | Traditional | PDF ↗ |
| K051228 | BIOZDX HEMODYNAMIC MONITOR AND 12-LEAD ECG | Cardiodynamics International Corp. | 2005-06-10 | Traditional | PDF ↗ |
| K041294 | BIOZDX HEMODYNAMIC MONITOR | Cardiodynamics International Corp. | 2004-12-08 | Traditional | PDF ↗ |
| K042113 | ZOE FLUID STATUS MONITOR | Noninvasive Medical Technologies, LLC | 2004-09-14 | Special | PDF ↗ |
| K041434 | C3 AND LIFEGARD ICG IMPEDANCE CARDIOGRAPHY MONITORS | Analogic Corp. | 2004-08-06 | Traditional | PDF ↗ |
| K032491 | ECOM CV4 ENDOTRACHEAL CARDIAC OUTPUT MONITOR | Imagyn Medical Technologies, Inc. | 2003-09-04 | Special | PDF ↗ |
| K021174 | ECOM ENDOTRACHIAL CARDIAC OUTPUT MONITOR | Imagyn Surgical | 2003-04-29 | Traditional | PDF ↗ |
| K014063 | TASK FORCE MONITOR 3040 | Cnsystems Medizintechnik GmbH | 2002-02-07 | Traditional | PDF ↗ |
| K014299 | SORBA STEORRA NON-INVASIVE IMPEDANCE CARDIOGRAPH | Sorba Medical Systems, Inc. | 2002-01-30 | Special | PDF ↗ |
| K011439 | MODIFICATION TO BIOZ.COM HEMODYNAMIC MONITOR | Cardiodynamics International Corp. | 2001-11-02 | Traditional | PDF ↗ |
| K011797 | BIOZTECT SENSOR AND BIOZTECT CABLE | Cardiodynamics International Corp. | 2001-07-03 | Special | PDF ↗ |
| K010164 | ICG MODULE | General Electric Medical Systems Information Techn | 2001-04-09 | Traditional | PDF ↗ |
| K001081 | BIOZ.PC HEMODYNAMIC MONITOR MODEL BZ-500/BZ-501; BIOZ.PC USER SOFTWARE INSTALLATION KIT MODEL BZ-810 | Cardiodynamics International Corp. | 2000-06-30 | Traditional | PDF ↗ |
| K001100 | BIOZ.COM HEMODYNAMIC MONITOR WITH BIOZ TECT SENSOR AND BIOZ TECT CABLE IMPEDANCE PLETHYSMOGRAPH | Cardiodynamics International Corp. | 2000-05-05 | Special | PDF ↗ |
| K981720 | IQ SYSTEM | Renaissance Technology, Inc. | 1999-02-08 | Traditional | PDF ↗ |
| K974725 | BIOZ.COM SYSTEM | Cardiodynamics International Corp. | 1998-03-18 | Traditional | PDF ↗ |
| K974621 | PERCUPUMP II WITH EDA | E-Z-Em, Inc. | 1998-01-27 | Traditional | PDF ↗ |
| K962783 | EDEMA SYSTEM | Bioanalogics, Inc. | 1997-10-23 | Traditional | PDF ↗ |
| K972320 | BIOZ SYSTEM & BIOZ PORTABLE | Cardiodynamics International Corp. | 1997-09-11 | Traditional | PDF ↗ |
| K952172 | HOTMAN | Hemo Sapiens, Inc. | 1997-06-10 | Traditional | PDF ↗ |
| K970603 | D SERIES ELECTRODE | Cmc Sense-It, Inc. | 1997-04-01 | Traditional | PDF ↗ |
| K961845 | PERCUPUMP II WITH EDA | E-Z-Em, Inc. | 1997-01-23 | Traditional | PDF ↗ |
| K963183 | BIOZ SYSTEM | Cardiodynamics International Corp. | 1996-11-26 | Traditional | PDF ↗ |
| K942227 | NICAS 2001 NONINVASIVE CARDIO-RESPIRATORY SYSTEM | C.L. Mcintosh & Assoc., Inc. | 1996-06-28 | Traditional | PDF ↗ |
| K922600 | FUTREX-5000 | Futrex, Inc. | 1995-12-28 | Traditional | PDF ↗ |
| K922601 | FUTREX-5000A | Futrex, Inc. | 1995-12-28 | Traditional | PDF ↗ |
| K951097 | BODYSTAY | Bodystat , Ltd. | 1995-11-22 | Traditional | PDF ↗ |
| K950389 | SORBA MODEL CIC-1000 NON-INVASIVE HEMODYNAMIC MONITOR | Sorba Medical Systems, Inc. | 1995-08-15 | Traditional | PDF ↗ |
| K941162 | HYPERGRAPH | Dermed Diagnostics, Inc. | 1994-12-15 | Traditional | PDF ↗ |
| K930599 | BODY FAT ANALYZER MODEL TBF-105 | Tanita Corp. of America | 1994-11-01 | Traditional | PDF ↗ |
| K932438 | MODEL IPM-1 IMPEDANCE PULSE MONITOR | Electro-Diagnostic Instruments | 1993-12-03 | Traditional | PDF ↗ |
| K910994 | MODIFIED SEISMOCARDIOGRAPH | Seismed Instruments, Inc. | 1992-01-15 | Traditional | PDF ↗ |
| K914200 | VASCUMAP MEDICAL AIR PLETHYSMOGRAPH | Carolina Medical Electronics | 1991-11-07 | Traditional | PDF ↗ |
| K911194 | IMPEDANCE PHLEBOGRAPH/PHOTOPLETHYSMOGRAPH-DVT-2000 | Rjl Systems, Inc. | 1991-09-30 | Traditional | PDF ↗ |
| K904970 | BODY COMPOSITION ANALYZER | Body Composition Analog, Inc. | 1991-03-07 | Traditional | PDF ↗ |
| K903700 | IPG-II MODULE | Life Sciences Manufacturing, Inc. | 1991-01-16 | Traditional | PDF ↗ |
| K904109 | BIO-IMPEDANCE ANALYZER | Xitron Technologies, Inc. | 1991-01-08 | Traditional | PDF ↗ |
| K902042 | EM-SCAN HP-2 PEDIATRIC BODY COMPOSITION ANALYZER | Em-Scan, Inc. | 1990-07-26 | Traditional | PDF ↗ |
| K900213 | PACEMAKER PATIENT ADAPTOR MODULE (PPAM) | Bomed Medical Mfg., Ltd. | 1990-06-28 | Traditional | PDF ↗ |
| K900321 | DYNATRON 330 BODY COMPOSITION ANALYZER | Dynatronics Laser Corp. | 1990-06-11 | Traditional | PDF ↗ |
| K900130 | MODIFIED SEISMOCARDIOGRAPH | Seismed Instruments, Inc. | 1990-03-28 | Traditional | PDF ↗ |
| K895588 | PORTABLE AIR PLETHYSMOGRAPH | Life Sciences Manufacturing, Inc. | 1990-03-27 | Traditional | PDF ↗ |
| K896034 | PROCORD MD3500 VASCULAR DIAGNOSTIC SYSTEM | D. E. Hokanson, Inc. | 1990-01-18 | Traditional | PDF ↗ |
| K892323 | SEISMOCARDIOGRAPH - SCG(TM) 1000 SERIES | Seismed Instruments, Inc. | 1989-10-30 | Traditional | PDF ↗ |
| K894892 | HD-2200 PNEUMO-DOP VASCULAR TESTING SYSTEM | Koven and Assoc., Inc. | 1989-10-27 | Traditional | PDF ↗ |
| K891928 | HOLTAIN BODY COMPOSITION ANALYSER | Seritex, Inc. | 1989-09-22 | Traditional | PDF ↗ |
| K893963 | VERIPOID 50 BIO-ELECTRICAL IMPEDANCE METER | V.S.B.B. Technologies, Inc. | 1989-09-05 | Traditional | PDF ↗ |
| K890408 | ADDITIONAL SOFTWARE TO CARDIODYNAMIC MONITOR | Bomed Medical Mfg., Ltd. | 1989-06-01 | Traditional | PDF ↗ |
| K883919 | NAPARIMA BIORESISTANCE METER & BODY COMP. ANALYZER | Naparima, Inc. | 1988-12-16 | Traditional | PDF ↗ |
| K881841 | DANNINGER TRIMCHECK(TM) PORTABLE & DESK TOP MODELS | Buckman Co., Inc. | 1988-12-13 | Traditional | PDF ↗ |
| K884033 | BIODYNAMICS MODEL 200 BODY COMPOSITION ANALYZER | Biodynamics Corp. | 1988-11-17 | Traditional | PDF ↗ |
| K881291 | AIR PLETHYSMOGRAPH MODEL APG-1000 | Aci Medical, Inc. | 1988-10-14 | Traditional | PDF ↗ |
| K881851 | VERIPOID 50 BIO-ELECTRICAL IMPEDANCE METER | Micro Medical, Ltd. | 1988-09-26 | Traditional | PDF ↗ |
| K881968 | BIODYNAMICS MODEL BI-400 BODY COMPOSITION ANALYZER | Biodynamics Corp. | 1988-07-28 | Traditional | PDF ↗ |
| K874938 | PERIPHERAL VASCULAR LABORATORY ASSISTANT MODEL 101 | Sp Innovations, Inc. | 1988-07-12 | Traditional | PDF ↗ |
| K880926 | BIOLOGICAL OHM METER, BES 200Z | Bioelectrical Sciences, Inc. | 1988-06-15 | Traditional | PDF ↗ |
| K874361 | BIODYNAMICS MODEL BI-300 BODY COMPOSITION ANALYZER | Biodynamics Corp. | 1988-03-16 | Traditional | PDF ↗ |
| K871040 | CONSULTANT BODY COMPOSITION ANALYZER | Body Composition Analog, Inc. | 1987-06-05 | Traditional | PDF ↗ |
| K863833 | BODY WATCH BODY COMPOSITION ANALYZER MODEL 2010 | Body Watch, Inc. | 1987-03-17 | Traditional | PDF ↗ |
| K864889 | OMNI-TRAK | Invivo Research Labs, Inc. | 1987-03-06 | Traditional | PDF ↗ |
| K862383 | MODIFIED MODEL BIA-103 BODY COMPOSITION ANALYZER | Rjl Systems, Inc. | 1987-02-03 | Traditional | PDF ↗ |
| K861205 | 1990A BIO-RESISTANCE BODY COMPOSITION ANALYZER | Valhalla Scientific | 1987-01-05 | Traditional | PDF ↗ |
| K862714 | BILATERAL IMPEDANCE PLETHYSMOGRAPH, BIP(TM) | Electro-Diagnostic Instruments | 1986-11-17 | Traditional | PDF ↗ |
| K860749 | HA-2 HUMAN BODY COMPOSITION ANALYZER | Dj Medical Instrument Corp. C/O Keller & Heckman | 1986-09-02 | Traditional | PDF ↗ |
| K853706 | BOMED-CDM | Bomed Medical Mfr., Ltd. | 1986-04-14 | Traditional | PDF ↗ |
| K852238 | IPG-300 | Thornton Associates, Inc. | 1985-10-11 | Traditional | PDF ↗ |
| K851415 | BODY ANALYSIS SYSTEM (DEEMED SE 87/09/18) | Medi-Sport Testing, Inc. | 1985-07-08 | Traditional | PDF ↗ |
Product code DSB · Class II · Cardiovascular. Data: openFDA.