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Empatica S.r.l.

FDA 510(k) & PMA Approved Devices — 9 products

Total Devices9
Categories5
Latest FDA decision2026-08-14
TypeNumberDevice NameCodeDateActions
510(k) K260374 Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus; EmbraceMini; Empatica Care; PKG Monitor by Empatica; Care PortalGYD2026-08-14 View
510(k) K252981 EmbraceMiniLEL2025-12-22 View
510(k) K250515 EpiMonitorPOS2025-06-19 View
510(k) K242737 Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalMWI2025-06-06 View
510(k) K232915 EpiMonitorPOS2024-02-15 View
510(k) K230457 Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalMWI2023-10-30 View
510(k) K221282 Empatica Health Monitoring PlatformDQA2022-11-20 View
510(k) K181861 EmbracePOS2018-12-20 View
510(k) K172935 EmbracePOS2018-01-26 View
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