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FDA 510(k)

CoVa Monitoring System 2

K-Number: K160899 · 2017-06-22

ApplicantTosense, Inc.
Decision Date2017-06-22
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CoVa Monitoring System 2 is a medical device manufactured by Tosense, Inc.. It received FDA 510(k) clearance on 2017-06-22 under approval number K160899. 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 CoVa Monitoring System 2?

CoVa Monitoring System 2 is a medical device that received FDA 510(k) clearance on 2017-06-22. It is manufactured by Tosense, Inc.. The 510(k) number is K160899.

When was CoVa Monitoring System 2 approved by the FDA?

CoVa Monitoring System 2 received FDA 510(k) clearance on 2017-06-22, under approval number K160899.

What company makes CoVa Monitoring System 2?

CoVa Monitoring System 2 is manufactured by Tosense, Inc..

What is the FDA product code for CoVa Monitoring System 2?

The FDA product code for CoVa Monitoring System 2 is MWI.

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Official Source

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