Empatica Health Monitoring Platform for Parkinson's Disease Monitoring +5 more— 510(k) K260374
Substantially EquivalentEmpatica S.r.l.
FDA 510(k) clearance K260374 for Empatica Health Monitoring Platform for Parkinson's Disease Monitoring +5 more, Substantially Equivalent on 2026-08-14. Applicant: Empatica S.r.l.. Device class: 2.
Clearance details
- Device name as filed
- Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus; EmbraceMini; Empatica Care; PKG Monitor by Empatica; Care Portal
- Applicant
- Empatica S.r.l.
- Product code
- Code GYD
- Device class
- Class 2
- Regulation
- 21 CFR 882.1950
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Milan, IT
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