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FDA 510(k)

Vital Sync Informatics Manager & Virtual Patient Monitoring Platform

K-Number: K160718 · 2016-11-14

ApplicantCovidien
Decision Date2016-11-14
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Vital Sync Informatics Manager & Virtual Patient Monitoring Platform is a medical device manufactured by Covidien. It received FDA 510(k) clearance on 2016-11-14 under approval number K160718. 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 Vital Sync Informatics Manager & Virtual Patient Monitoring Platform?

Vital Sync Informatics Manager & Virtual Patient Monitoring Platform is a medical device that received FDA 510(k) clearance on 2016-11-14. It is manufactured by Covidien. The 510(k) number is K160718.

When was Vital Sync Informatics Manager & Virtual Patient Monitoring Platform approved by the FDA?

Vital Sync Informatics Manager & Virtual Patient Monitoring Platform received FDA 510(k) clearance on 2016-11-14, under approval number K160718.

What company makes Vital Sync Informatics Manager & Virtual Patient Monitoring Platform?

Vital Sync Informatics Manager & Virtual Patient Monitoring Platform is manufactured by Covidien.

What is the FDA product code for Vital Sync Informatics Manager & Virtual Patient Monitoring Platform?

The FDA product code for Vital Sync Informatics Manager & Virtual Patient Monitoring Platform is MWI.

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Official Source

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