FDA 510(k)

BB-613-BPM

K 號：K241066 · 2025-01-14

決定日期2025-01-14

產品代碼DXN

諮詢委員會履歷

決定相當於

器材摘要

BB-613-BPM is the device name listed in this FDA 510(k) record. The listed applicant is Biobeat Technologies , Ltd.. It received FDA 510(k) clearance on 2025-01-14 under 510(k) number K241066. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BB-613-BPM?

BB-613-BPM is a medical device that received FDA 510(k) clearance on 2025-01-14. The listed applicant is Biobeat Technologies , Ltd.. The 510(k) number is K241066.

When did BB-613-BPM receive FDA 510(k) clearance?

BB-613-BPM received FDA 510(k) clearance on 2025-01-14, under 510(k) number K241066.

Who is the listed applicant for BB-613-BPM?

The FDA 510(k) record lists Biobeat Technologies , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BB-613-BPM?

The FDA product code for BB-613-BPM is DXN.

其他以 Biobeat Technologies , Ltd. 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。

K222010Biobeat 平台-2 和 BB-613WP 贴片 K212153Biobeat 平台，BB-613WP 贴片 K190792BB-613WP

相關器械（代碼：DXN）

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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