FDA 510(k)

BB-613WP

K 號：K190792 · 2019-08-22

決定日期2019-08-22

產品代碼DQA

諮詢委員會履歷

決定相當於

器材摘要

BB-613WP 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 2019-08-22 under 510(k) number K190792. 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 BB-613WP?

BB-613WP is a medical device that received FDA 510(k) clearance on 2019-08-22. The listed applicant is Biobeat Technologies , Ltd.. The 510(k) number is K190792.

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

BB-613WP received FDA 510(k) clearance on 2019-08-22, under 510(k) number K190792.

Who is the listed applicant for BB-613WP?

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-613WP?

The FDA product code for BB-613WP is DQA.

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。

K241066BB-613-BPM K222010Biobeat 平台-2 和 BB-613WP 贴片 K212153Biobeat 平台，BB-613WP 贴片

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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