FDA 510(k)

WellDoc BlueStar（WellDoc糖尿病管理系统及糖尿病管理-Rx系统）

K号: K162225 · 2016-11-22

决定日期2016-11-22

产品代码MRZ

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

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.

常见问题

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.

列明Welldoc, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K222888BlueStar CGM 胰岛素剂量计算器 K230813BlueStar 和 BlueStar Rx K203434BlueStar Rx K193654BlueStar Rx K190013WellDoc 蓝星 K162532WellDoc蓝星，WellDoc蓝星Rx

查看所有 7 个设备 →

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。