EpiMonitor— 510(k) K250515

Substantially Equivalent

Empatica S.r.l.

FDA 510(k) clearance K250515 for EpiMonitor, Substantially Equivalent on 2025-06-19. Applicant: Empatica S.r.l..

Clearance details

Applicant: Empatica S.r.l.
Product code: Code POS
Advisory panel: Neurology
Date received: 2025-02-21
Decision date: 2025-06-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Milano, IT

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