Inogen Rove 4 Portable Oxygen Concentrator
K号: K222086 · 2022-12-09
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申请人Inogen
决定日期2022-12-09
产品代码CAW
咨询委员会AN
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决定实质等同
器械摘要
Inogen Rove 4 Portable Oxygen Concentrator is the device name listed in this FDA 510(k) record. The listed applicant is Inogen. It received FDA 510(k) clearance on 2022-12-09 under 510(k) number K222086. The device is classified under product code CAW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Inogen Rove 4 Portable Oxygen Concentrator?
Inogen Rove 4 Portable Oxygen Concentrator is a medical device that received FDA 510(k) clearance on 2022-12-09. The listed applicant is Inogen. The 510(k) number is K222086.
When did Inogen Rove 4 Portable Oxygen Concentrator receive FDA 510(k) clearance?
Inogen Rove 4 Portable Oxygen Concentrator received FDA 510(k) clearance on 2022-12-09, under 510(k) number K222086.
Who is the listed applicant for Inogen Rove 4 Portable Oxygen Concentrator?
The FDA 510(k) record lists Inogen as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Inogen Rove 4 Portable Oxygen Concentrator?
The FDA product code for Inogen Rove 4 Portable Oxygen Concentrator is CAW.
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相关器械（代码：CAW）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
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官方来源
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