FDA 510(k)

Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22

Número K: K193542 · 2020-10-08

Data da decisão2020-10-08

Código do produtoKDI

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22 is the device name listed in this FDA 510(k) record. The listed applicant is Bellco Srl. It received FDA 510(k) clearance on 2020-10-08 under 510(k) number K193542. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22?

Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22 is a medical device that received FDA 510(k) clearance on 2020-10-08. The listed applicant is Bellco Srl. The 510(k) number is K193542.

When did Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22 receive FDA 510(k) clearance?

Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22 received FDA 510(k) clearance on 2020-10-08, under 510(k) number K193542.

Who is the listed applicant for Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22?

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

What is the FDA product code for Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22?

The FDA product code for Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22 is KDI.

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Outros registros que listam Bellco Srl como candidato(a)

K231406ClearumTM HS K160558RAPIDO HOLLOW-FIBRE DIALYZERS

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Fonte oficial

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