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510(k) K242737

Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal by Empatica S.R.L. — Product Code MWI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2025
Date Received
September 11, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type

Other clearances by Empatica S.R.L.

  • K252981 — EmbraceMini (December 22, 2025)
  • K250515 — EpiMonitor (June 19, 2025)
  • K232915 — EpiMonitor (February 15, 2024)
  • 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 MWI

  • K250135 — WAVE Clinical Platform (2.0.000) (January 16, 2026)
  • K241766 — QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid) (August 27, 2025)
  • K241958 — WARD-CSS (v1.2.x) (February 14, 2025)
  • K243146 — iCare APP (February 3, 2025)
  • K241411 — Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM) (December 20, 2024)
  • K243216 — Sensinel Cardiopulmonary Management (CPM) System (ADCP1100) (December 10, 2024)
  • K233446 — AMC Health CareConsole (September 27, 2024)
  • K240236 — Happy Ring Health Monitoring System (September 24, 2024)
  • K233354 — WVSM Pro (Series) (500-0030-XX) (June 26, 2024)
  • K232111 — NeoBeat, NeoBeat Mini (June 25, 2024)