FDA 510(k)

Belun 睡眠系统 BLS-100

K号: K222579 · 2023-02-23

决定日期2023-02-23

产品代码MNR

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决定实质等同

器械摘要

Belun Sleep System BLS-100 is the device name listed in this FDA 510(k) record. The listed applicant is Belun Technology Company Limited. It received FDA 510(k) clearance on 2023-02-23 under 510(k) number K222579. 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 Belun Sleep System BLS-100?

Belun Sleep System BLS-100 is a medical device that received FDA 510(k) clearance on 2023-02-23. The listed applicant is Belun Technology Company Limited. The 510(k) number is K222579.

When did Belun Sleep System BLS-100 receive FDA 510(k) clearance?

Belun Sleep System BLS-100 received FDA 510(k) clearance on 2023-02-23, under 510(k) number K222579.

Who is the listed applicant for Belun Sleep System BLS-100?

The FDA 510(k) record lists Belun Technology Company Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Belun Sleep System BLS-100?

The FDA product code for Belun Sleep System BLS-100 is MNR.

列明Belun Technology Company Limited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。

K234110Belun 环 BLR-200（BLR-200）K211407Belun 环 BLR-100X K191417Belun 环 K180174Belun 环

官方来源

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