FDA 510(k)

貝倫環 BLR-100X

K 號：K211407 · 2021-10-21

決定日期2021-10-21

產品代碼DQA

諮詢委員會履歷

決定相當於

器材摘要

Belun Ring BLR-100X 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 2021-10-21 under 510(k) number K211407. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Belun Ring BLR-100X?

Belun Ring BLR-100X is a medical device that received FDA 510(k) clearance on 2021-10-21. The listed applicant is Belun Technology Company Limited. The 510(k) number is K211407.

When did Belun Ring BLR-100X receive FDA 510(k) clearance?

Belun Ring BLR-100X received FDA 510(k) clearance on 2021-10-21, under 510(k) number K211407.

Who is the listed applicant for Belun Ring BLR-100X?

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 Ring BLR-100X?

The FDA product code for Belun Ring BLR-100X is DQA.

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。

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相關器械（代碼：DQA）

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。

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官方來源

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