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FDA 510(k)

WellDoc 藍星（WellDoc 糖尿病管理系統及糖尿病管理-Rx 系統）

K 號：K162225 · 2016-11-22

申請人Welldoc, Inc.
決定日期2016-11-22
產品代碼MRZ
諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。
決定相當於

器材摘要

WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System is the device name listed in this FDA 510(k) record. The listed applicant is Welldoc, Inc.. It received FDA 510(k) clearance on 2016-11-22 under 510(k) number K162225. The device is classified under product code MRZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System?

WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System is a medical device that received FDA 510(k) clearance on 2016-11-22. The listed applicant is Welldoc, Inc.. The 510(k) number is K162225.

When did WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System receive FDA 510(k) clearance?

WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System received FDA 510(k) clearance on 2016-11-22, under 510(k) number K162225.

Who is the listed applicant for WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System?

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

What is the FDA product code for WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System?

The FDA product code for WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System is MRZ.

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 Welldoc, Inc. 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。

K222888藍星CGM胰島素劑量計算器K230813藍星及藍星RxK203434藍星藥妝K193654藍星藥妝K190013WellDoc 藍星K162532WellDoc 藍星，WellDoc 藍星 藥妝

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相關器械（代碼：MRZ）

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。

K230718UTC 3mL 藥品藥筒Gilero, LLCK220695精英生物醫學解決方案 計劃劑量請求纜線Elite Biomedical SolutionsK201634RG 3ml 藥品藥筒Chengdu Shifeng Medical Technology Co., Ltd.K193654藍星藥妝Welldoc, Inc.K191910太空站 MRIB. Braun Melsugen AGK190013WellDoc 藍星Welldoc, Inc.

官方來源

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