FDA 510(k)

TD-4277 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 4277

K-Number: K100322 · 2010-06-28

Decision Date2010-06-28

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

TD-4277 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 4277 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 2010-06-28 under 510(k) number K100322. 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-4277 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 4277?

TD-4277 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 4277 is a medical device that received FDA 510(k) clearance on 2010-06-28. The listed applicant is Taidoc Technology Corporation. The 510(k) number is K100322.

When did TD-4277 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 4277 receive FDA 510(k) clearance?

TD-4277 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 4277 received FDA 510(k) clearance on 2010-06-28, under 510(k) number K100322.

Who is the listed applicant for TD-4277 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 4277?

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-4277 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 4277?

The FDA product code for TD-4277 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 4277 is NBW. This falls under the OB/GYN category.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.