FDA 510(k)

Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal

K-Nummer: K242737 · 2025-06-06

Entscheidungsdatum2025-06-06

ProduktcodeMWI

BeratungsausschussCV

EntscheidungSubstantially Equivalent

Produktübersicht

Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal is the device name listed in this FDA 510(k) record. The listed applicant is Empatica S.r.l.. It received FDA 510(k) clearance on 2025-06-06 under 510(k) number K242737. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal?

Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal is a medical device that received FDA 510(k) clearance on 2025-06-06. The listed applicant is Empatica S.r.l.. The 510(k) number is K242737.

When did Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal receive FDA 510(k) clearance?

Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal received FDA 510(k) clearance on 2025-06-06, under 510(k) number K242737.

Who is the listed applicant for Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal?

The FDA 510(k) record lists Empatica S.r.l. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal?

The FDA product code for Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal is MWI.

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Weitere Einträge mit Empatica S.r.l. als Antragsteller

K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus; EmbraceMini; Empatica Care; PKG Monitor by Empatica; Care Portal K252981EmbraceMini K250515EpiMonitor K232915EpiMonitor K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal K221282Empatica Health Monitoring Platform

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Offizielle Quelle

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