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FDA 510(k)

WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM

K-Number: K112370 · 2011-10-14

ApplicantWelldoc, Inc.
Decision Date2011-10-14
Product CodeMRZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER 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 2011-10-14 under 510(k) number K112370. 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 DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM?

WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM is a medical device that received FDA 510(k) clearance on 2011-10-14. The listed applicant is Welldoc, Inc.. The 510(k) number is K112370.

When did WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM receive FDA 510(k) clearance?

WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM received FDA 510(k) clearance on 2011-10-14, under 510(k) number K112370.

Who is the listed applicant for WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER 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 DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM?

The FDA product code for WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM is MRZ.

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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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