EmbraceMini— 510(k) K252981

Substantially Equivalent

Empatica S.r.l.

FDA 510(k) clearance K252981 for EmbraceMini, Substantially Equivalent on 2025-12-22. Applicant: Empatica S.r.l..

Clearance details

Applicant: Empatica S.r.l.
Product code: Code LEL
Advisory panel: Neurology
Date received: 2025-09-17
Decision date: 2025-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milan, IT

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