FDA 510(k)

气体模块 3

K号: K180788 · 2018-10-24

申请人Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

决定日期2018-10-24

产品代码BZK

咨询委员会AN 请注意，由于您没有提供完整的医疗设备监管文本，我无法提供完整的翻译。如果您能提供完整的文本，我将很乐意为您翻译。

决定实质等同

器械摘要

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.

常见问题

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.

列明Shenzhen Mindray Bio-Medical Electronics Co., Ltd.为申报人的其他记录

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