FDA 510(k)

Sistema de Anestesia A5 (A5); Sistema de Anestesia A7 (A7)

Número K: K253330 · 2026-06-25

RequerenteShenzhen Mindray Bio-Medical Electronics Co., Ltd.

Data da decisão2026-06-25

Código do produtoBSZ

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

A5 Anesthesia System (A5); A7 Anesthesia System (A7) 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 2026-06-25 under 510(k) number K253330. 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 A5 Anesthesia System (A5); A7 Anesthesia System (A7)?

A5 Anesthesia System (A5); A7 Anesthesia System (A7) is a medical device that received FDA 510(k) clearance on 2026-06-25. The listed applicant is Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The 510(k) number is K253330.

When did A5 Anesthesia System (A5); A7 Anesthesia System (A7) receive FDA 510(k) clearance?

A5 Anesthesia System (A5); A7 Anesthesia System (A7) received FDA 510(k) clearance on 2026-06-25, under 510(k) number K253330.

Who is the listed applicant for A5 Anesthesia System (A5); A7 Anesthesia System (A7)?

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 A5 Anesthesia System (A5); A7 Anesthesia System (A7)?

The FDA product code for A5 Anesthesia System (A5); A7 Anesthesia System (A7) is BSZ.

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Fonte oficial

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