DC-Air 和 Athlos-1 及 Athlos-Air
K号: K211688 · 2021-07-22
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申请人Athlos OY
决定日期2021-07-22
产品代码MUH
咨询委员会DE
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决定实质等同
器械摘要
DC-Air and Athlos-1 and Athlos-Air is the device name listed in this FDA 510(k) record. The listed applicant is Athlos OY. It received FDA 510(k) clearance on 2021-07-22 under 510(k) number K211688. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the DC-Air and Athlos-1 and Athlos-Air?
DC-Air and Athlos-1 and Athlos-Air is a medical device that received FDA 510(k) clearance on 2021-07-22. The listed applicant is Athlos OY. The 510(k) number is K211688.
When did DC-Air and Athlos-1 and Athlos-Air receive FDA 510(k) clearance?
DC-Air and Athlos-1 and Athlos-Air received FDA 510(k) clearance on 2021-07-22, under 510(k) number K211688.
Who is the listed applicant for DC-Air and Athlos-1 and Athlos-Air?
The FDA 510(k) record lists Athlos OY as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for DC-Air and Athlos-1 and Athlos-Air?
The FDA product code for DC-Air and Athlos-1 and Athlos-Air is MUH.
相关临床试验
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相关器械（代码：MUH）
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
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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