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Empatica S.r.l.

FDA 510(k) & PMA Approved Devices — 8 products

Total Devices8
Categories4
Latest Approval2025-12-22
TypeNumberDevice NameCodeDate
510(k) K252981 EmbraceMini LEL 2025-12-22 View
510(k) K250515 EpiMonitor POS 2025-06-19 View
510(k) K242737 Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal MWI 2025-06-06 View
510(k) K232915 EpiMonitor POS 2024-02-15 View
510(k) K230457 Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal MWI 2023-10-30 View
510(k) K221282 Empatica Health Monitoring Platform DQA 2022-11-20 View
510(k) K181861 Embrace POS 2018-12-20 View
510(k) K172935 Embrace POS 2018-01-26 View