FDA 510(k)

Proov Test

Número K: K191462 · 2020-02-27

Data da decisão2020-02-27

Código do produtoQKE

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

Proov Test is the device name listed in this FDA 510(k) record. The listed applicant is Mfb Fertility, Inc.. It received FDA 510(k) clearance on 2020-02-27 under 510(k) number K191462. The device is classified under product code QKE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Proov Test?

Proov Test is a medical device that received FDA 510(k) clearance on 2020-02-27. The listed applicant is Mfb Fertility, Inc.. The 510(k) number is K191462.

When did Proov Test receive FDA 510(k) clearance?

Proov Test received FDA 510(k) clearance on 2020-02-27, under 510(k) number K191462.

Who is the listed applicant for Proov Test?

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

What is the FDA product code for Proov Test?

The FDA product code for Proov Test is QKE.

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