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FDA 510(k)

WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System

K-Number: K162225 · 2016-11-22

ApplicantWelldoc, Inc.
Decision Date2016-11-22
Product CodeMRZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Welldoc, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K222888BlueStar CGM insulin dose calculatorK230813BlueStar and BlueStar RxK203434BlueStar RxK193654BlueStar RxK190013WellDoc BlueStarK162532WellDoc BlueStar, WellDoc BlueStar Rx

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Related Devices (Code: MRZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230718UTC 3mL Medication CartridgeGilero, LLCK220695Elite Biomedical Solutions Dose Request CordElite Biomedical SolutionsK201634RG 3ml Medication CartridgeChengdu Shifeng Medical Technology Co., Ltd.K193654BlueStar RxWelldoc, Inc.K191910SpaceStation MRIB. Braun Melsugen AGK190013WellDoc BlueStarWelldoc, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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