FDA 510(k)

Bio Guard Air/Water & Suction Valves

Número K: K192059 · 2019-09-17

RequerenteUnited States Endoscopy Group, Inc.

Data da decisão2019-09-17

Código do produtoODC

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Bio Guard Air/Water & Suction Valves is the device name listed in this FDA 510(k) record. The listed applicant is United States Endoscopy Group, Inc.. It received FDA 510(k) clearance on 2019-09-17 under 510(k) number K192059. 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 Bio Guard Air/Water & Suction Valves?

Bio Guard Air/Water & Suction Valves is a medical device that received FDA 510(k) clearance on 2019-09-17. The listed applicant is United States Endoscopy Group, Inc.. The 510(k) number is K192059.

When did Bio Guard Air/Water & Suction Valves receive FDA 510(k) clearance?

Bio Guard Air/Water & Suction Valves received FDA 510(k) clearance on 2019-09-17, under 510(k) number K192059.

Who is the listed applicant for Bio Guard Air/Water & Suction Valves?

The FDA 510(k) record lists United States Endoscopy Group, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bio Guard Air/Water & Suction Valves?

The FDA product code for Bio Guard Air/Water & Suction Valves is ODC.

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Fonte oficial

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