Decision Date2023-07-20
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
Oxygen concentrator is a medical device manufactured by Zhengzhou Olive Electronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-07-20 under approval number K222920. The device is classified under product code CAW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Oxygen concentrator?
Oxygen concentrator is a medical device that received FDA 510(k) clearance on 2023-07-20. It is manufactured by Zhengzhou Olive Electronic Technology Co., Ltd.. The 510(k) number is K222920.
When was Oxygen concentrator approved by the FDA?
Oxygen concentrator received FDA 510(k) clearance on 2023-07-20, under approval number K222920.
What company makes Oxygen concentrator?
Oxygen concentrator is manufactured by Zhengzhou Olive Electronic Technology Co., Ltd..
What is the FDA product code for Oxygen concentrator?
The FDA product code for Oxygen concentrator is CAW.
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Official Source
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