Panels › Cardiovascular › Product code DSB · Class 2
Plethysmograph, Impedance
Regulation 870.2770
2510(k)s in 12 months (115 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in DSB
| Company | 510(k)s | Recalls |
|---|---|---|
| Cardiodynamics International Corp. | 11 | 0 |
| ImpediMed Limited | 5 | 0 |
| Bomed Medical Mfr., Ltd. | 4 | 0 |
| Noninvasive Medical Technologies, Inc. | 4 | 0 |
| Biodynamics Corp. | 3 | 0 |
| Cardio Kinetics, Inc. | 3 | 0 |
| Cheetah Medical, Inc. | 3 | 0 |
| Electro-Diagnostic Instruments | 3 | 0 |
| Life Sciences Manufacturing, Inc. | 3 | 0 |
| Osypka Medical, Inc. | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 17, 2026 | K260224 | MySOZO Software version 6.1.0.1 (SW version 6.1.0.1) ImpediMed Limited, AU | DSB |
| Nov 24, 2025 | K250634 | BCM2-Body Composition Monitor Fresenius Medical Care Renal Therapies Group, LLC | DSB |
| Oct 16, 2025 | K243727 | Re:Balans Mode Sensors AS, NO | DSB |
| Sep 9, 2025 | K250922 | Edema Guard Monitor (EGM) CardioSet-001 Cardioset Medical , Ltd., IL | DSB |
| Oct 17, 2023 | K232089 | SOZO Pro ImpediMed Limited, AU | DSB |
| Jun 16, 2023 | K223217 | Zynex Monitoring System, Model CM-1600 Zynex Medical, Inc. | DSB |
| Jul 29, 2022 | K211585 | Bodyport Cardiac Scale Bodyport, Inc. | DSB |
| Apr 19, 2021 | K203473 | SOZO ImpediMed Limited, AU | DSB |
| Oct 2, 2020 | K193410 | SOZO Body Fluid Analyzer ImpediMed Limited, AU | DSB |
| Feb 21, 2020 | K191697 | Cardiac Monitor 1500 Zynex Medical, Inc. | DSB |
| Feb 28, 2019 | K180479 | ReDS System Sensible Medical Innovations , Ltd., IL | DSB |
| Mar 14, 2018 | K172431 | Cardiovascular Analzyer Physiowave, Inc. | DSB |
| Dec 22, 2017 | K172507 | SOZO ImpediMed Limited, AU | DSB |
| Sep 19, 2017 | K172196 | ECOM Cardiac Output Monitoring System Ecom Medical, Inc. | DSB |
| Aug 6, 2015 | K150095 | ReDs Wearable System Sensible Medical Innovations , Ltd., IL | DSB |
| Jun 5, 2015 | K142503 | IMED-Z FLUID STATUS MONITOR Intersection Medical, Inc. | DSB |
| Feb 12, 2014 | K140102 | PHYSIOFLOW Q-LINK Vasocom, Inc. | DSB |
| Jan 22, 2014 | K133301 | ZOE FLUID STATUS MONITOR Noninvasive Medical Technologies, Inc. | DSB |
| Dec 20, 2013 | K131765 | ECOM ENDOTRACHEAL CARDIAC OUTPUT MONITOR SYSTEM Conmed Corporation | DSB |
| Jun 28, 2013 | K131509 | ZOE FLUID STATUS MONITOR Noninvasive Medical Technologies, Inc. | DSB |
| Nov 13, 2012 | K112830 | ZOEFLUID STATUS MONITOR (MODEL ZOE 2B) Noninvasive Medical Technologies, Inc. | DSB |
| Jun 3, 2011 | K110645 | BIO Z CARDIO PROFILE HEMODYNAMIC MONITOR Sonosite,Inc. | DSB |
| Jan 25, 2011 | K103166 | CHEETAH RELIANT Cheetah Medical, Inc. | DSB |
| Dec 3, 2010 | K103283 | PHYSIOFLOW ENDURO Vasocom, Inc. | DSB |
| Jun 18, 2009 | K080941 | BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM N.I. Medical, Ltd. | DSB |
| May 28, 2009 | K090602 | CARDIODYNAMICS BIOZ RX, MODEL 7101-SYS Cardiodynamics International Corp. | DSB |
| Dec 15, 2008 | K083093 | CHEETAH RELIANT Cheetah Medical, Inc. | DSB |
| Oct 8, 2008 | K082242 | ICON, MODEL C3 Osypka Medical, Inc. | DSB |
| May 30, 2008 | K081035 | AESCULON C2, AESCULON CHF CLINIC C2, AESCULON HYPERTENSION CLINIC C2 AND AESCULON PACEMAKER CLINIC C2 Osypka Medical, Inc. | DSB |
| Apr 10, 2008 | K060387 | PHYSIOFLOW SYSTEM Vasocom, Inc. | DSB |
| Feb 1, 2008 | K070985 | AESCULON CHF, HYPERTENSION & PACEMAKER CLINIC Osypka Medical, Inc. | DSB |
| Jan 16, 2008 | K072662 | CHEETAH RELIANT, CHEETAH ACTIVE Cheetah Medical, Inc., IL | DSB |
| Sep 26, 2007 | K070156 | BIOZ DX HEMODYNAMIC MONITOR WITH PHILIPS 12-LEAD ECG, MODEL 5100 Cardiodynamics International Corp. | DSB |
| Jul 16, 2007 | K070500 | BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM, MODEL NICAS 2004 SLIM Ni Medical | DSB |
| Jun 10, 2005 | K051228 | BIOZDX HEMODYNAMIC MONITOR AND 12-LEAD ECG Cardiodynamics International Corp. | DSB |
| Dec 8, 2004 | K041294 | BIOZDX HEMODYNAMIC MONITOR Cardiodynamics International Corp. | DSB |
| Sep 14, 2004 | K042113 | ZOE FLUID STATUS MONITOR Noninvasive Medical Technologies, LLC | DSB |
| Aug 6, 2004 | K041434 | C3 AND LIFEGARD ICG IMPEDANCE CARDIOGRAPHY MONITORS Analogic Corp. | DSB |
| Sep 4, 2003 | K032491 | ECOM CV4 ENDOTRACHEAL CARDIAC OUTPUT MONITOR Imagyn Medical Technologies, Inc. | DSB |
| Apr 29, 2003 | K021174 | ECOM ENDOTRACHIAL CARDIAC OUTPUT MONITOR Imagyn Surgical | DSB |
| Feb 7, 2002 | K014063 | TASK FORCE MONITOR 3040 Cnsystems Medizintechnik GmbH, AT | DSB |
| Jan 30, 2002 | K014299 | SORBA STEORRA NON-INVASIVE IMPEDANCE CARDIOGRAPH Sorba Medical Systems, Inc. | DSB |
| Nov 2, 2001 | K011439 | MODIFICATION TO BIOZ.COM HEMODYNAMIC MONITOR Cardiodynamics International Corp. | DSB |
| Jul 3, 2001 | K011797 | BIOZTECT SENSOR AND BIOZTECT CABLE Cardiodynamics International Corp. | DSB |
| Apr 9, 2001 | K010164 | ICG MODULE General Electric Medical Systems Information Techn | DSB |
| Jun 30, 2000 | K001081 | BIOZ.PC HEMODYNAMIC MONITOR MODEL BZ-500/BZ-501; BIOZ.PC USER SOFTWARE INSTALLATION KIT MODEL BZ-810 Cardiodynamics International Corp. | DSB |
| May 5, 2000 | K001100 | BIOZ.COM HEMODYNAMIC MONITOR WITH BIOZ TECT SENSOR AND BIOZ TECT CABLE IMPEDANCE PLETHYSMOGRAPH Cardiodynamics International Corp. | DSB |
| Feb 8, 1999 | K981720 | IQ SYSTEM Renaissance Technology, Inc. | DSB |
| Mar 18, 1998 | K974725 | BIOZ.COM SYSTEM Cardiodynamics International Corp. | DSB |
| Jan 27, 1998 | K974621 | PERCUPUMP II WITH EDA E-Z-Em, Inc. | DSB |
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