FDA 510(k)

Ava Fertility Tracker

Número K: K200163 · 2021-01-19

RequerenteAva AG

Data da decisão2021-01-19

Código do produtoLHD

DecisãoSubstantially Equivalent

Resumo do dispositivo

Ava Fertility Tracker is the device name listed in this FDA 510(k) record. The listed applicant is Ava AG. It received FDA 510(k) clearance on 2021-01-19 under 510(k) number K200163. The device is classified under product code LHD. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Ava Fertility Tracker?

Ava Fertility Tracker is a medical device that received FDA 510(k) clearance on 2021-01-19. The listed applicant is Ava AG. The 510(k) number is K200163.

When did Ava Fertility Tracker receive FDA 510(k) clearance?

Ava Fertility Tracker received FDA 510(k) clearance on 2021-01-19, under 510(k) number K200163.

Who is the listed applicant for Ava Fertility Tracker?

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

What is the FDA product code for Ava Fertility Tracker?

The FDA product code for Ava Fertility Tracker is LHD.

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