FDA 510(k)

FORA G30 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4241

K-Number: K090187 · 2009-05-12

Decision Date2009-05-12

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

FORA G30 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4241 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 2009-05-12 under 510(k) number K090187. 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 FORA G30 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4241?

FORA G30 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4241 is a medical device that received FDA 510(k) clearance on 2009-05-12. The listed applicant is Taidoc Technology Corporation. The 510(k) number is K090187.

When did FORA G30 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4241 receive FDA 510(k) clearance?

FORA G30 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4241 received FDA 510(k) clearance on 2009-05-12, under 510(k) number K090187.

Who is the listed applicant for FORA G30 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4241?

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 FORA G30 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4241?

The FDA product code for FORA G30 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4241 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.