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510(k) K232915

EpiMonitor by Empatica S.R.L. — Product Code POS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 2024
Date Received
September 19, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Physiological Signal Based Seizure Monitoring System
Device Class
Class II
Regulation Number
882.1580
Review Panel
NE
Submission Type

The Physiological signal based seizure monitoring system is a prescription device that uses physiological signal to identify abnormal physiological activity that may be associated with a seizure. The System does not predict seizure onsets, and is not intended as a standalone seizure monitoring device.

Other clearances by Empatica S.R.L.

  • K252981 — EmbraceMini (December 22, 2025)
  • K250515 — EpiMonitor (June 19, 2025)
  • K242737 — Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal (June 6, 2025)
  • K230457 — Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal (October 30, 2023)
  • K221282 — Empatica Health Monitoring Platform (November 20, 2022)
  • K181861 — Embrace (December 20, 2018)
  • K172935 — Embrace (January 26, 2018)

Other clearances for product code POS

  • K251506 — Nelli (Version 7.11) (November 21, 2025)
  • K243199 — NightWatch+ US (July 12, 2025)
  • K250515 — EpiMonitor (June 19, 2025)
  • K243515 — EpiWatch Monitoring System (March 7, 2025)
  • K200276 — SPEAC System (February 6, 2021)
  • K182180 — SPEAC System (May 11, 2019)
  • K181861 — Embrace (December 20, 2018)
  • K172935 — Embrace (January 26, 2018)
  • DEN140033 — Companion (February 16, 2017)