FDA 510(k)

PK AIM

Número K: K170908 · 2017-05-19

Data da decisão2017-05-19

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

PK AIM is the device name listed in this FDA 510(k) record. The listed applicant is Gyrus Acmi, Inc.. It received FDA 510(k) clearance on 2017-05-19 under 510(k) number K170908. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the PK AIM?

PK AIM is a medical device that received FDA 510(k) clearance on 2017-05-19. The listed applicant is Gyrus Acmi, Inc.. The 510(k) number is K170908.

When did PK AIM receive FDA 510(k) clearance?

PK AIM received FDA 510(k) clearance on 2017-05-19, under 510(k) number K170908.

Who is the listed applicant for PK AIM?

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

What is the FDA product code for PK AIM?

The FDA product code for PK AIM is GEI.

Outros registros que listam Gyrus Acmi, Inc. como candidato(a)

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Fonte oficial

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