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FDA 510(k)

WellDoc BlueStar

K-Number: K190013 · 2019-11-04

ApplicantWelldoc, Inc.
Decision Date2019-11-04
Product CodeMRZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

WellDoc BlueStar is the device name listed in this FDA 510(k) record. The listed applicant is Welldoc, Inc.. It received FDA 510(k) clearance on 2019-11-04 under 510(k) number K190013. 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 BlueStar is a medical device that received FDA 510(k) clearance on 2019-11-04. The listed applicant is Welldoc, Inc.. The 510(k) number is K190013.

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

WellDoc BlueStar received FDA 510(k) clearance on 2019-11-04, under 510(k) number K190013.

Who is the listed applicant for WellDoc BlueStar?

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?

The FDA product code for WellDoc BlueStar 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.

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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 AGK173531Lockbox 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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