FDA 510(k)

CoVa Monitoring System 2

Número K: K160899 · 2017-06-22

Data da decisão2017-06-22

Código do produtoMWI

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

CoVa Monitoring System 2 is the device name listed in this FDA 510(k) record. The listed applicant is Tosense, Inc.. It received FDA 510(k) clearance on 2017-06-22 under 510(k) number K160899. 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 CoVa Monitoring System 2?

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

When did CoVa Monitoring System 2 receive FDA 510(k) clearance?

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

Who is the listed applicant for CoVa Monitoring System 2?

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

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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