FDA 510(k)

Vitals360 Multi-Vitals Mobile Monitor

Número K: K210086 · 2021-05-20

Data da decisão2021-05-20

Código do produtoMWI

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Vitals360 Multi-Vitals Mobile Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Vocare, Inc.. It received FDA 510(k) clearance on 2021-05-20 under 510(k) number K210086. 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 Vitals360 Multi-Vitals Mobile Monitor?

Vitals360 Multi-Vitals Mobile Monitor is a medical device that received FDA 510(k) clearance on 2021-05-20. The listed applicant is Vocare, Inc.. The 510(k) number is K210086.

When did Vitals360 Multi-Vitals Mobile Monitor receive FDA 510(k) clearance?

Vitals360 Multi-Vitals Mobile Monitor received FDA 510(k) clearance on 2021-05-20, under 510(k) number K210086.

Who is the listed applicant for Vitals360 Multi-Vitals Mobile Monitor?

The FDA 510(k) record lists Vocare, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vitals360 Multi-Vitals Mobile Monitor?

The FDA product code for Vitals360 Multi-Vitals Mobile Monitor is MWI.

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