DSB
- Product code
- DSB
- Device name
- Plethysmograph, Impedance
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.2770
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 5
- Summaries archived here
- 5 (direct download)
- 510(k) clearances (all years, FDA)
- 115 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (5)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260224 | 2026-08-17 | ImpediMed Limited | MySOZO Software version 6.1.0.1 (SW version 6.1.0.1) | |
| K250634 | 2025-11-24 | Fresenius Medical Care Renal Therapies… | BCM2-Body Composition Monitor | |
| K243727 | 2025-10-16 | Mode Sensors AS | Re:Balans | |
| K250922 | 2025-09-09 | Cardioset Medical , Ltd. | Edema Guard Monitor (EGM) CardioSet-001 | |
| K232089 | 2023-10-17 | ImpediMed Limited | SOZO Pro |
Official FDA classification page: DSB
Classification and pathway per current FDA publications. Data from openFDA (CC0).