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FDA 510(k)

BlueStar Rx

K-Number: K193654 · 2020-04-07

ApplicantWelldoc, Inc.
Decision Date2020-04-07
Product CodeMRZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

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 2020-04-07 under 510(k) number K193654. 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 BlueStar Rx?

BlueStar Rx is a medical device that received FDA 510(k) clearance on 2020-04-07. The listed applicant is Welldoc, Inc.. The 510(k) number is K193654.

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

BlueStar Rx received FDA 510(k) clearance on 2020-04-07, under 510(k) number K193654.

Who is the listed applicant for 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 BlueStar Rx?

The FDA product code for BlueStar Rx 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 RxK190013WellDoc BlueStarK162532WellDoc BlueStar, WellDoc BlueStar RxK162225WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System

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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.K191910SpaceStation MRIB. Braun Melsugen AGK190013WellDoc BlueStarWelldoc, Inc.K173531Lockbox for Perfusor Space PCA Infusion PumpB.Braun Medical, 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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