Biobeat 平台，BB-613WP 贴片
K 號：K212153 · 2022-03-25
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器材摘要
Biobeat Platform, BB-613WP Patch 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 2022-03-25 under 510(k) number K212153. 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 Biobeat Platform, BB-613WP Patch?
Biobeat Platform, BB-613WP Patch is a medical device that received FDA 510(k) clearance on 2022-03-25. The listed applicant is Biobeat Technologies , Ltd.. The 510(k) number is K212153.
When did Biobeat Platform, BB-613WP Patch receive FDA 510(k) clearance?
Biobeat Platform, BB-613WP Patch received FDA 510(k) clearance on 2022-03-25, under 510(k) number K212153.
Who is the listed applicant for Biobeat Platform, BB-613WP Patch?
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 Biobeat Platform, BB-613WP Patch?
The FDA product code for Biobeat Platform, BB-613WP Patch is DQA.
相關臨床試驗
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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。
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
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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