FDA 510(k)

Sistema de Anestesia A8, A9

Número K: K201957 · 2021-03-26

RequerenteShenzhen Mindray Bio-Medical Electronics Co., Ltd.

Data da decisão2021-03-26

Código do produtoBSZ

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

A8, A9 Anesthesia System is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2021-03-26 under 510(k) number K201957. The device is classified under product code BSZ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the A8, A9 Anesthesia System?

A8, A9 Anesthesia System is a medical device that received FDA 510(k) clearance on 2021-03-26. The listed applicant is Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The 510(k) number is K201957.

When did A8, A9 Anesthesia System receive FDA 510(k) clearance?

A8, A9 Anesthesia System received FDA 510(k) clearance on 2021-03-26, under 510(k) number K201957.

Who is the listed applicant for A8, A9 Anesthesia System?

The FDA 510(k) record lists Shenzhen Mindray Bio-Medical Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for A8, A9 Anesthesia System?

The FDA product code for A8, A9 Anesthesia System is BSZ.

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Dispositivos Relacionados (Código: BSZ)

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Fonte oficial

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