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FDA 510(k)

Vitals360 Multi-Vitals Mobile Monitor

K-Number: K210086 · 2021-05-20

ApplicantVocare, Inc.
Decision Date2021-05-20
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Vitals360 Multi-Vitals Mobile Monitor is a medical device manufactured by Vocare, Inc.. It received FDA 510(k) clearance on 2021-05-20 under approval number K210086. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Vocare, Inc.. The 510(k) number is K210086.

When was Vitals360 Multi-Vitals Mobile Monitor approved by the FDA?

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

What company makes Vitals360 Multi-Vitals Mobile Monitor?

Vitals360 Multi-Vitals Mobile Monitor is manufactured by Vocare, Inc..

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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Official Source

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