FDA 510(k)

Gas Module 3

N.º K: K180788 · 2018-10-24

SolicitanteShenzhen Mindray Bio-Medical Electronics Co., Ltd.

Fecha de decisión2018-10-24

Código de productoBZK

Comité asesorAN

DecisiónSubstantially Equivalent

Resumen del dispositivo

Gas Module 3 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 2018-10-24 under 510(k) number K180788. The device is classified under product code BZK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Gas Module 3?

Gas Module 3 is a medical device that received FDA 510(k) clearance on 2018-10-24. The listed applicant is Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The 510(k) number is K180788.

When did Gas Module 3 receive FDA 510(k) clearance?

Gas Module 3 received FDA 510(k) clearance on 2018-10-24, under 510(k) number K180788.

Who is the listed applicant for Gas Module 3?

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 Gas Module 3?

The FDA product code for Gas Module 3 is BZK.

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Fuente oficial

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