FDA 510(k)

Classic

K号: K203477 · 2021-02-25

决定日期2021-02-25

产品代码LRK

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决定实质等同

器械摘要

Classic is the device name listed in this FDA 510(k) record. The listed applicant is Orthoapnea S.L.. It received FDA 510(k) clearance on 2021-02-25 under 510(k) number K203477. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Classic?

Classic is a medical device that received FDA 510(k) clearance on 2021-02-25. The listed applicant is Orthoapnea S.L.. The 510(k) number is K203477.

When did Classic receive FDA 510(k) clearance?

Classic received FDA 510(k) clearance on 2021-02-25, under 510(k) number K203477.

Who is the listed applicant for Classic?

The FDA 510(k) record lists Orthoapnea S.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Classic?

The FDA product code for Classic is LRK.

列明Orthoapnea S.L.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。

K202651NOA睡眠呼吸暂停和打鼾设备

官方来源

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