FDA 510(k)

BioGuard Air/Water and Suction Valves

Número K: K203630 · 2021-01-08

Data da decisão2021-01-08

Código do produtoODC

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

BioGuard Air/Water and Suction Valves is the device name listed in this FDA 510(k) record. The listed applicant is Steris Corporations. It received FDA 510(k) clearance on 2021-01-08 under 510(k) number K203630. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the BioGuard Air/Water and Suction Valves?

BioGuard Air/Water and Suction Valves is a medical device that received FDA 510(k) clearance on 2021-01-08. The listed applicant is Steris Corporations. The 510(k) number is K203630.

When did BioGuard Air/Water and Suction Valves receive FDA 510(k) clearance?

BioGuard Air/Water and Suction Valves received FDA 510(k) clearance on 2021-01-08, under 510(k) number K203630.

Who is the listed applicant for BioGuard Air/Water and Suction Valves?

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

What is the FDA product code for BioGuard Air/Water and Suction Valves?

The FDA product code for BioGuard Air/Water and Suction Valves is ODC.

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Fonte oficial

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