Re:Balans— 510(k) K243727
Substantially EquivalentMode Sensors AS
FDA 510(k) clearance K243727 for Re:Balans, Substantially Equivalent on 2025-10-16. Applicant: Mode Sensors AS. Device class: 2.
Clearance details
- Applicant
- Mode Sensors AS
- Product code
- Code DSB
- Device class
- Class 2
- Regulation
- 21 CFR 870.2770
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Trondheim, NO
Recent devices under product code DSB
view allData sourced from openFDA. This site is unofficial and independent of the FDA.