FDA 510(k)

Onera 睡眠测试系统 (Onera STS)

K号: K210593 · 2022-04-06

决定日期2022-04-06

产品代码MNR

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决定实质等同

器械摘要

Onera Sleep Test System (Onera STS) is the device name listed in this FDA 510(k) record. The listed applicant is Onera B.V.. It received FDA 510(k) clearance on 2022-04-06 under 510(k) number K210593. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Onera Sleep Test System (Onera STS)?

Onera Sleep Test System (Onera STS) is a medical device that received FDA 510(k) clearance on 2022-04-06. The listed applicant is Onera B.V.. The 510(k) number is K210593.

When did Onera Sleep Test System (Onera STS) receive FDA 510(k) clearance?

Onera Sleep Test System (Onera STS) received FDA 510(k) clearance on 2022-04-06, under 510(k) number K210593.

Who is the listed applicant for Onera Sleep Test System (Onera STS)?

The FDA 510(k) record lists Onera B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Onera Sleep Test System (Onera STS)?

The FDA product code for Onera Sleep Test System (Onera STS) is MNR.

列明Onera B.V.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。

K253668Onera SleepMap (SLEEPMAP)K243220Onera STS 2 (ONERA STS 2)K223573Onera 睡眠测试系统 (Onera STS)

官方来源

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