FDA 510(k)Air Relax Plus型号AR-3.0
K号: K211460 · 2021-05-25
决定日期2021-05-25
产品代码IRP
咨询委员会PM
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决定实质等同
器械摘要
Air Relax Plus Model AR-3.0 is the device name listed in this FDA 510(k) record. The listed applicant is Diode Art Engineering Doing Business AS Air Relax. It received FDA 510(k) clearance on 2021-05-25 under 510(k) number K211460. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Air Relax Plus Model AR-3.0?
Air Relax Plus Model AR-3.0 is a medical device that received FDA 510(k) clearance on 2021-05-25. The listed applicant is Diode Art Engineering Doing Business AS Air Relax. The 510(k) number is K211460.
When did Air Relax Plus Model AR-3.0 receive FDA 510(k) clearance?
Air Relax Plus Model AR-3.0 received FDA 510(k) clearance on 2021-05-25, under 510(k) number K211460.
Who is the listed applicant for Air Relax Plus Model AR-3.0?
The FDA 510(k) record lists Diode Art Engineering Doing Business AS Air Relax as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Air Relax Plus Model AR-3.0?
The FDA product code for Air Relax Plus Model AR-3.0 is IRP.
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列明Diode Art Engineering Doing Business AS Air Relax为申报人的其他记录
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。
相关器械（代码：IRP）
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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