FDA 510(k)

WellDoc 藍星，WellDoc 藍星藥妝

K 號：K162532 · 2017-01-12

決定日期2017-01-12

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 BlueStar Rx is the device name listed in this FDA 510(k) record. The listed applicant is Welldoc, Inc.. It received FDA 510(k) clearance on 2017-01-12 under 510(k) number K162532. 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 BlueStar Rx?

WellDoc BlueStar, WellDoc BlueStar Rx is a medical device that received FDA 510(k) clearance on 2017-01-12. The listed applicant is Welldoc, Inc.. The 510(k) number is K162532.

When did WellDoc BlueStar, WellDoc BlueStar Rx receive FDA 510(k) clearance?

WellDoc BlueStar, WellDoc BlueStar Rx received FDA 510(k) clearance on 2017-01-12, under 510(k) number K162532.

Who is the listed applicant for WellDoc BlueStar, WellDoc BlueStar Rx?

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 BlueStar Rx?

The FDA product code for WellDoc BlueStar, WellDoc BlueStar Rx is MRZ.

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Rx K203434藍星藥妝 K193654藍星藥妝 K190013WellDoc 藍星 K162225WellDoc 藍星（WellDoc 糖尿病管理系統及糖尿病管理-Rx 系統）

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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, LLC K220695精英生物醫學解決方案計劃劑量請求纜線Elite Biomedical Solutions K201634RG 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 AG K190013WellDoc 藍星Welldoc, Inc.

官方來源

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