EmbraceMini— 510(k) K252981
Substantially EquivalentEmpatica S.r.l.
FDA 510(k) clearance K252981 for EmbraceMini, Substantially Equivalent on 2025-12-22. Applicant: Empatica S.r.l.. Device class: 2.
Clearance details
- Applicant
- Empatica S.r.l.
- Product code
- Code LEL
- Device class
- Class 2
- Regulation
- 21 CFR 882.5050
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Milan, IT
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Data sourced from openFDA. This site is unofficial and independent of the FDA.