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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 a medical device manufactured by Welldoc, Inc.. It received FDA 510(k) clearance on 2016-11-22 under approval 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. It is manufactured by Welldoc, Inc.. The 510(k) number is K162225.

When was WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System approved by the FDA?

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

What company makes WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System?

WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System is manufactured by Welldoc, Inc..

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 Devices by Welldoc, Inc.

K162532WellDoc BlueStar, WellDoc BlueStar Rx K190013WellDoc BlueStar K193654BlueStar Rx K203434BlueStar Rx K222888BlueStar CGM insulin dose calculator K230813BlueStar and BlueStar Rx

View all 7 devices →

Related Devices (Code: MRZ)

K160492Hospira Sapphire SetsHospira, Inc. K171346Sapphire SetsIcu Medical K162532WellDoc BlueStar, WellDoc BlueStar RxWelldoc, Inc. K173531Lockbox for Perfusor Space PCA Infusion PumpB.Braun Medical, Inc. K190013WellDoc BlueStarWelldoc, Inc. K193654BlueStar RxWelldoc, 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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