Product code DSB
- Device name
- Plethysmograph, Impedance
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.2770
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250634 | BCM2-Body Composition Monitor | Fresenius Medical Care Renal Therapies Group, LLC | 2025-11-24 |
| K243727 | Re:Balans | Mode Sensors AS | 2025-10-16 |
| K250922 | Edema Guard Monitor (EGM) CardioSet-001 | Cardioset Medical , Ltd. | 2025-09-09 |
| K232089 | SOZO Pro | ImpediMed Limited | 2023-10-17 |
| K223217 | Zynex Monitoring System, Model CM-1600 | Zynex Medical, Inc. | 2023-06-16 |
| K211585 | Bodyport Cardiac Scale | Bodyport, Inc. | 2022-07-29 |
| K203473 | SOZO | ImpediMed Limited | 2021-04-19 |
| K193410 | SOZO Body Fluid Analyzer | ImpediMed Limited | 2020-10-02 |
| K191697 | Cardiac Monitor 1500 | Zynex Medical, Inc. | 2020-02-21 |
| K180479 | ReDS System | Sensible Medical Innovations , Ltd. | 2019-02-28 |
| K172431 | Cardiovascular Analzyer | Physiowave, Inc. | 2018-03-14 |
| K172507 | SOZO | ImpediMed Limited | 2017-12-22 |
| K172196 | ECOM™ Cardiac Output Monitoring System | Ecom Medical, Inc. | 2017-09-19 |
| K150095 | ReDs Wearable System | Sensible Medical Innovations , Ltd. | 2015-08-06 |
| K142503 | IMED-Z FLUID STATUS MONITOR | Intersection Medical, Inc. | 2015-06-05 |
| K140102 | PHYSIOFLOW Q-LINK | Vasocom, Inc. | 2014-02-12 |
| K133301 | ZOE FLUID STATUS MONITOR | Noninvasive Medical Technologies, Inc. | 2014-01-22 |
| K131765 | ECOM ENDOTRACHEAL CARDIAC OUTPUT MONITOR SYSTEM | Conmed Corporation | 2013-12-20 |
| K131509 | ZOE FLUID STATUS MONITOR | Noninvasive Medical Technologies, Inc. | 2013-06-28 |
| K112830 | ZOEFLUID STATUS MONITOR (MODEL ZOE 2B) | Noninvasive Medical Technologies, Inc. | 2012-11-13 |
| K110645 | BIO Z CARDIO PROFILE HEMODYNAMIC MONITOR | Sonosite,Inc. | 2011-06-03 |
| K103166 | CHEETAH RELIANT | Cheetah Medical, Inc. | 2011-01-25 |
| K103283 | PHYSIOFLOW ENDURO | Vasocom, Inc. | 2010-12-03 |
| K080941 | BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM | N.I. Medical, Ltd. | 2009-06-18 |
| K090602 | CARDIODYNAMICS BIOZ RX, MODEL 7101-SYS | Cardiodynamics International Corp. | 2009-05-28 |
| K083093 | CHEETAH RELIANT | Cheetah Medical, Inc. | 2008-12-15 |
| K082242 | ICON, MODEL C3 | Osypka Medical, Inc. | 2008-10-08 |
| K081035 | AESCULON C2, AESCULON CHF CLINIC C2, AESCULON HYPERTENSION CLINIC C2 AND AESCULON PACEMAKER CLINIC C2 | Osypka Medical, Inc. | 2008-05-30 |
| K060387 | PHYSIOFLOW SYSTEM | Vasocom, Inc. | 2008-04-10 |
| K070985 | AESCULON CHF, HYPERTENSION & PACEMAKER CLINIC | Osypka Medical, Inc. | 2008-02-01 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08719327003763 | Finapres | Finapres Medical Systems B.V. | 2022-05-25 |
| 08719327007129 | Finapres | Finapres Medical Systems B.V. | 2018-11-30 |
| 08719327007112 | Finapres | Finapres Medical Systems B.V. | 2018-11-30 |
| 08719327007105 | Finapres | Finapres Medical Systems B.V. | 2018-11-30 |
| 08719327003794 | Finapres | Finapres Medical Systems B.V. | 2018-11-30 |
| 08719327003787 | Finapres | Finapres Medical Systems B.V. | 2018-11-30 |
| 08719327003770 | Finapres | Finapres Medical Systems B.V. | 2018-11-30 |
| 17630039300842 | EmpowerSync® Power Supply | Bracco Injeneering SA | 2017-10-26 |
| 17630039300798 | Injector | Bracco Injeneering SA | 2017-10-26 |
| 08719327003749 | Finapres | Finapres Medical Systems B.V. | 2016-09-24 |
| 08719326027616 | Finapres | Finapres Medical Systems B.V. | 2016-09-24 |
| 08719327003732 | Finapres | Finapres Medical Systems B.V. | 2016-09-24 |
| 08719327003725 | Finapres | Finapres Medical Systems B.V. | 2016-09-24 |
| 08719326027654 | Finapres | Finapres Medical Systems B.V. | 2016-09-24 |
| 08719326027623 | Finapres | Finapres Medical Systems B.V. | 2016-09-24 |
| 08719326027630 | Finapres | Finapres Medical Systems B.V. | 2016-09-24 |
| 08719326027647 | Finapres | Finapres Medical Systems B.V. | 2016-09-24 |
| 08719327003671 | Finapres | Finapres Medical Systems B.V. | 2016-09-24 |
| 08719327003602 | Finapres | Finapres Medical Systems B.V. | 2016-09-24 |
| 08719327003619 | Finapres | Finapres Medical Systems B.V. | 2016-09-24 |
| 08719327003626 | Finapres | Finapres Medical Systems B.V. | 2016-09-24 |
| 08719327003633 | Finapres | Finapres Medical Systems B.V. | 2016-09-24 |
| 08719327003640 | Finapres | Finapres Medical Systems B.V. | 2016-09-24 |
| 08719327003657 | Finapres | Finapres Medical Systems B.V. | 2016-09-24 |
| 08719327003664 | Finapres | Finapres Medical Systems B.V. | 2016-09-24 |
| 17630039300422 | EDA Module Kit | Bracco Injeneering SA | 2016-09-20 |
| 17630039300477 | Remote Control | Bracco Injeneering SA | 2016-09-20 |
| 17630039300484 | EmpowerSync® Power Supply | Bracco Injeneering SA | 2016-09-20 |
| 17630039300743 | Injector | Bracco Injeneering SA | 2016-09-20 |
| 17630039300767 | Remote Control (Onyx) | Bracco Injeneering SA | 2016-09-20 |