Gas Module 3
K-Number: K180788 · 2018-10-24
Decision Date2018-10-24
Product CodeBZK
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
Gas Module 3 is a medical device manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2018-10-24 under approval number K180788. The device is classified under product code BZK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Gas Module 3?
Gas Module 3 is a medical device that received FDA 510(k) clearance on 2018-10-24. It is manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The 510(k) number is K180788.
When was Gas Module 3 approved by the FDA?
Gas Module 3 received FDA 510(k) clearance on 2018-10-24, under approval number K180788.
What company makes Gas Module 3?
Gas Module 3 is manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd..
What is the FDA product code for Gas Module 3?
The FDA product code for Gas Module 3 is BZK.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.