FDA 510(k)

Clue Birth Control

Número K: K193330 · 2021-02-18

Data da decisão2021-02-18

Código do produtoPYT

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

Clue Birth Control is the device name listed in this FDA 510(k) record. The listed applicant is Biowink GmbH. It received FDA 510(k) clearance on 2021-02-18 under 510(k) number K193330. The device is classified under product code PYT. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Clue Birth Control?

Clue Birth Control is a medical device that received FDA 510(k) clearance on 2021-02-18. The listed applicant is Biowink GmbH. The 510(k) number is K193330.

When did Clue Birth Control receive FDA 510(k) clearance?

Clue Birth Control received FDA 510(k) clearance on 2021-02-18, under 510(k) number K193330.

Who is the listed applicant for Clue Birth Control?

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

What is the FDA product code for Clue Birth Control?

The FDA product code for Clue Birth Control is PYT.

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