FDA 510(k)

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

Número K: K230457 · 2023-10-30

Data da decisão2023-10-30

Código do produtoMWI

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

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 2023-10-30 under 510(k) number K230457. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

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 2023-10-30. The listed applicant is Empatica S.r.l.. The 510(k) number is K230457.

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 2023-10-30, under 510(k) number K230457.

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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Outros registros que listam Empatica S.r.l. como candidato(a)

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Fonte oficial

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