FDA 510(k)

Gas Module 3

K-번호: K180788 · 2018-10-24

신청자Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

결정일2018-10-24

제품 코드BZK

자문 위원회AN

결정Substantially Equivalent

기기 요약

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.

자주 묻는 질문

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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