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FDA 510(k)

TD-4257 BLOOD GLUCOSE MONITORING SYSTEMS,TD 4257 MULTI BLOOD GLUCOSE MONITORING SYSTEMS

K-Number: K112963 · 2011-11-22

ApplicantTaidoc Technology Corporation
Decision Date2011-11-22
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TD-4257 BLOOD GLUCOSE MONITORING SYSTEMS,TD 4257 MULTI BLOOD GLUCOSE MONITORING SYSTEMS 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 2011-11-22 under 510(k) number K112963. 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 TD-4257 BLOOD GLUCOSE MONITORING SYSTEMS,TD 4257 MULTI BLOOD GLUCOSE MONITORING SYSTEMS?

TD-4257 BLOOD GLUCOSE MONITORING SYSTEMS,TD 4257 MULTI BLOOD GLUCOSE MONITORING SYSTEMS is a medical device that received FDA 510(k) clearance on 2011-11-22. The listed applicant is Taidoc Technology Corporation. The 510(k) number is K112963.

When did TD-4257 BLOOD GLUCOSE MONITORING SYSTEMS,TD 4257 MULTI BLOOD GLUCOSE MONITORING SYSTEMS receive FDA 510(k) clearance?

TD-4257 BLOOD GLUCOSE MONITORING SYSTEMS,TD 4257 MULTI BLOOD GLUCOSE MONITORING SYSTEMS received FDA 510(k) clearance on 2011-11-22, under 510(k) number K112963.

Who is the listed applicant for TD-4257 BLOOD GLUCOSE MONITORING SYSTEMS,TD 4257 MULTI BLOOD GLUCOSE MONITORING SYSTEMS?

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 TD-4257 BLOOD GLUCOSE MONITORING SYSTEMS,TD 4257 MULTI BLOOD GLUCOSE MONITORING SYSTEMS?

The FDA product code for TD-4257 BLOOD GLUCOSE MONITORING SYSTEMS,TD 4257 MULTI BLOOD GLUCOSE MONITORING SYSTEMS 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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