FDA 510(k)

Bronchoscope System

Número K: K222910 · 2023-04-11

RequerenteShenzhen HugeMed Medical Technical Development Co., Ltd.

Data da decisão2023-04-11

Código do produtoEOQ

Comité consultivoEN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Bronchoscope System is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen HugeMed Medical Technical Development Co., Ltd.. It received FDA 510(k) clearance on 2023-04-11 under 510(k) number K222910. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Bronchoscope System?

Bronchoscope System is a medical device that received FDA 510(k) clearance on 2023-04-11. The listed applicant is Shenzhen HugeMed Medical Technical Development Co., Ltd.. The 510(k) number is K222910.

When did Bronchoscope System receive FDA 510(k) clearance?

Bronchoscope System received FDA 510(k) clearance on 2023-04-11, under 510(k) number K222910.

Who is the listed applicant for Bronchoscope System?

The FDA 510(k) record lists Shenzhen HugeMed Medical Technical Development Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bronchoscope System?

The FDA product code for Bronchoscope System is EOQ.

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Dispositivos Relacionados (Código: EOQ)

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Fonte oficial

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