Re:Balans— 510(k) K243727

Substantially Equivalent

Mode Sensors AS

FDA 510(k) clearance K243727 for Re:Balans, Substantially Equivalent on 2025-10-16. Applicant: Mode Sensors AS.

Clearance details

Applicant: Mode Sensors AS
Product code: Code DSB
Advisory panel: Cardiovascular
Date received: 2024-12-03
Decision date: 2025-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Trondheim, NO

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