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FDA 510(k)

Biobeat 平台-2 和 BB-613WP 贴片

K 號：K222010 · 2022-12-30

申請人Biobeat Technologies , Ltd.
決定日期2022-12-30
產品代碼DQA
諮詢委員會履歷
決定相當於

器材摘要

Biobeat Platform-2 and 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 2022-12-30 under 510(k) number K222010. 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-2 and BB-613WP Patch?

Biobeat Platform-2 and BB-613WP Patch is a medical device that received FDA 510(k) clearance on 2022-12-30. The listed applicant is Biobeat Technologies , Ltd.. The 510(k) number is K222010.

When did Biobeat Platform-2 and BB-613WP Patch receive FDA 510(k) clearance?

Biobeat Platform-2 and BB-613WP Patch received FDA 510(k) clearance on 2022-12-30, under 510(k) number K222010.

Who is the listed applicant for Biobeat Platform-2 and 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-2 and BB-613WP Patch?

The FDA product code for Biobeat Platform-2 and BB-613WP Patch is DQA.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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-BPMK212153Biobeat 平台，BB-613WP 贴片K190792BB-613WP

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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