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FDA 510(k)

EpiMonitor

K-Number: K250515 · 2025-06-19

ApplicantEmpatica S.r.l.
Decision Date2025-06-19
Product CodePOS
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EpiMonitor is a medical device manufactured by Empatica S.r.l.. It received FDA 510(k) clearance on 2025-06-19 under approval number K250515. The device is classified under product code POS. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EpiMonitor?

EpiMonitor is a medical device that received FDA 510(k) clearance on 2025-06-19. It is manufactured by Empatica S.r.l.. The 510(k) number is K250515.

When was EpiMonitor approved by the FDA?

EpiMonitor received FDA 510(k) clearance on 2025-06-19, under approval number K250515.

What company makes EpiMonitor?

EpiMonitor is manufactured by Empatica S.r.l..

What is the FDA product code for EpiMonitor?

The FDA product code for EpiMonitor is POS.

Other Devices by Empatica S.r.l.

K181861Embrace K172935Embrace K221282Empatica Health Monitoring Platform K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal K232915EpiMonitor K252981EmbraceMini

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Related Devices (Code: POS)

DEN140033CompanionLgch, Inc. K181861EmbraceEmpatica S.r.l. K172935EmbraceEmpatica S.r.l. K182180SPEAC SystemBrain Sentinel, Inc. K200276SPEAC SystemBrain Sentinel, Inc. K232915EpiMonitorEmpatica S.r.l.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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