FDA 510(k)

貝倫睡眠系統 BLS-100

K 號：K222579 · 2023-02-23

決定日期2023-02-23

產品代碼MNR

諮詢委員會AN

決定相當於

器材摘要

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.

常見問題

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.

其他以 Belun Technology Company Limited 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K234110貝倫環 BLR-200 (BLR-200)K211407貝倫環 BLR-100X K191417貝倫環 K180174貝倫環

相關器械（代碼：MNR）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K260949一次性睡眠監測帶（CNSAC）CNSAC Medshop GmbH K254042觀察者PAT SWItamar Medical , Ltd.K260050WRAP系統Huneo, LLC K253148RX-1 睡眠Vivaquant, Inc. Dba Rhythm Express K252628CASSIEWesper, Inc.K252497SANSA HSATHuxley Medical

官方來源

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