FDA 510(k)

Dispositivo de Occluder Amsel

Número K: K172479 · 2017-09-14

Data da decisão2017-09-14

Código do produtoFZP

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Amsel Occluder Device is the device name listed in this FDA 510(k) record. The listed applicant is Amsel Medical. It received FDA 510(k) clearance on 2017-09-14 under 510(k) number K172479. The device is classified under product code FZP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Amsel Occluder Device?

Amsel Occluder Device is a medical device that received FDA 510(k) clearance on 2017-09-14. The listed applicant is Amsel Medical. The 510(k) number is K172479.

When did Amsel Occluder Device receive FDA 510(k) clearance?

Amsel Occluder Device received FDA 510(k) clearance on 2017-09-14, under 510(k) number K172479.

Who is the listed applicant for Amsel Occluder Device?

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

What is the FDA product code for Amsel Occluder Device?

The FDA product code for Amsel Occluder Device is FZP.

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