DSB — Plethysmograph, Impedance Class II
FDA product code DSB covers "Plethysmograph, Impedance", a Class II medical device regulated under 21 CFR 870.2770. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DSB
- Device Class
- Class II
- Regulation Number
- 870.2770
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K250634 | fresenius medical care renal therapies group | BCM2-Body Composition Monitor | November 24, 2025 |
| K243727 | mode sensors | Re:Balans | October 16, 2025 |
| K250922 | cardioset medical | Edema Guard Monitor (EGM) CardioSet-001 | September 9, 2025 |
| K232089 | impedimed limited | SOZO Pro | October 17, 2023 |
| K223217 | zynex medical | Zynex Monitoring System, Model CM-1600 | June 16, 2023 |
| K211585 | bodyport | Bodyport Cardiac Scale | July 29, 2022 |
| K203473 | impedimed limited | SOZO | April 19, 2021 |
| K193410 | impedimed limited | SOZO Body Fluid Analyzer | October 2, 2020 |
| K191697 | zynex medical | Cardiac Monitor 1500 | February 21, 2020 |
| K180479 | sensible medical innovations | ReDS System | February 28, 2019 |
| K172431 | physiowave | Cardiovascular Analzyer | March 14, 2018 |
| K172507 | impedimed limited | SOZO | December 22, 2017 |
| K172196 | ecom medical | ECOM Cardiac Output Monitoring System | September 19, 2017 |
| K150095 | sensible medical innovations | ReDs Wearable System | August 6, 2015 |
| K142503 | intersection medical | IMED-Z FLUID STATUS MONITOR | June 5, 2015 |
| K140102 | vasocom | PHYSIOFLOW Q-LINK | February 12, 2014 |
| K133301 | noninvasive medical technologies | ZOE FLUID STATUS MONITOR | January 22, 2014 |
| K131765 | conmed corporation | ECOM ENDOTRACHEAL CARDIAC OUTPUT MONITOR SYSTEM | December 20, 2013 |
| K131509 | noninvasive medical technologies | ZOE FLUID STATUS MONITOR | June 28, 2013 |
| K112830 | noninvasive medical technologies | ZOEFLUID STATUS MONITOR (MODEL ZOE 2B) | November 13, 2012 |