FDA 510(k)

FORA TD-4244 & TD-4245 BLOOD GLUCOSE MONITORING SYSTESM

K-Number: K081715 · 2008-12-17

Decision Date2008-12-17

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

FORA TD-4244 & TD-4245 BLOOD GLUCOSE MONITORING SYSTESM 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 2008-12-17 under 510(k) number K081715. 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 TD-4244 & TD-4245 BLOOD GLUCOSE MONITORING SYSTESM?

FORA TD-4244 & TD-4245 BLOOD GLUCOSE MONITORING SYSTESM is a medical device that received FDA 510(k) clearance on 2008-12-17. The listed applicant is Taidoc Technology Corporation. The 510(k) number is K081715.

When did FORA TD-4244 & TD-4245 BLOOD GLUCOSE MONITORING SYSTESM receive FDA 510(k) clearance?

FORA TD-4244 & TD-4245 BLOOD GLUCOSE MONITORING SYSTESM received FDA 510(k) clearance on 2008-12-17, under 510(k) number K081715.

Who is the listed applicant for FORA TD-4244 & TD-4245 BLOOD GLUCOSE MONITORING SYSTESM?

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 TD-4244 & TD-4245 BLOOD GLUCOSE MONITORING SYSTESM?

The FDA product code for FORA TD-4244 & TD-4245 BLOOD GLUCOSE MONITORING SYSTESM 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.