FDA 510(k)

ARTHROTAP

Número K: K201816 · 2020-10-16

Data da decisão2020-10-16

Código do produtoFMF

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

ARTHROTAP is the device name listed in this FDA 510(k) record. The listed applicant is Accuro Technologies, Inc.. It received FDA 510(k) clearance on 2020-10-16 under 510(k) number K201816. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ARTHROTAP?

ARTHROTAP is a medical device that received FDA 510(k) clearance on 2020-10-16. The listed applicant is Accuro Technologies, Inc.. The 510(k) number is K201816.

When did ARTHROTAP receive FDA 510(k) clearance?

ARTHROTAP received FDA 510(k) clearance on 2020-10-16, under 510(k) number K201816.

Who is the listed applicant for ARTHROTAP?

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

What is the FDA product code for ARTHROTAP?

The FDA product code for ARTHROTAP is FMF.

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Fonte oficial

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