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FDA 510(k)

U-RIGHT TD-4238 AND TD-4246 BLOOD GLUCOSE MONITORING SYSTEM FORA G31 BLOOD GLUCOSE MONITORING SYSTEM, TD-4256 BLOOD GLUC

K-Number: K092902 · 2010-03-02

ApplicantTaidoc Technology Corporation
Decision Date2010-03-02
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

U-RIGHT TD-4238 AND TD-4246 BLOOD GLUCOSE MONITORING SYSTEM FORA G31 BLOOD GLUCOSE MONITORING SYSTEM, TD-4256 BLOOD GLUC is the device name listed in this FDA 510(k) record. The listed applicant is Taidoc Technology Corporation. It received FDA 510(k) clearance on 2010-03-02 under 510(k) number K092902. The device is classified under product code NBW. It was reviewed by the CH advisory panel. Product code NBW falls under the category of OB/GYN, which includes obstetric and gynecological diagnostic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the U-RIGHT TD-4238 AND TD-4246 BLOOD GLUCOSE MONITORING SYSTEM FORA G31 BLOOD GLUCOSE MONITORING SYSTEM, TD-4256 BLOOD GLUC?

U-RIGHT TD-4238 AND TD-4246 BLOOD GLUCOSE MONITORING SYSTEM FORA G31 BLOOD GLUCOSE MONITORING SYSTEM, TD-4256 BLOOD GLUC is a medical device that received FDA 510(k) clearance on 2010-03-02. The listed applicant is Taidoc Technology Corporation. The 510(k) number is K092902.

When did U-RIGHT TD-4238 AND TD-4246 BLOOD GLUCOSE MONITORING SYSTEM FORA G31 BLOOD GLUCOSE MONITORING SYSTEM, TD-4256 BLOOD GLUC receive FDA 510(k) clearance?

U-RIGHT TD-4238 AND TD-4246 BLOOD GLUCOSE MONITORING SYSTEM FORA G31 BLOOD GLUCOSE MONITORING SYSTEM, TD-4256 BLOOD GLUC received FDA 510(k) clearance on 2010-03-02, under 510(k) number K092902.

Who is the listed applicant for U-RIGHT TD-4238 AND TD-4246 BLOOD GLUCOSE MONITORING SYSTEM FORA G31 BLOOD GLUCOSE MONITORING SYSTEM, TD-4256 BLOOD GLUC?

The FDA 510(k) record lists Taidoc Technology Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for U-RIGHT TD-4238 AND TD-4246 BLOOD GLUCOSE MONITORING SYSTEM FORA G31 BLOOD GLUCOSE MONITORING SYSTEM, TD-4256 BLOOD GLUC?

The FDA product code for U-RIGHT TD-4238 AND TD-4246 BLOOD GLUCOSE MONITORING SYSTEM FORA G31 BLOOD GLUCOSE MONITORING SYSTEM, TD-4256 BLOOD GLUC is NBW. This falls under the OB/GYN category.

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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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