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FDA 510(k)

CLEVER CHEK BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4209, -4222, -4225 AND -4226 AND ACHTUNG BLOOD GLUCOSE MONITORING

K-Number: K073494 · 2008-04-02

ApplicantTaidoc Technology Corporation
Decision Date2008-04-02
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CLEVER CHEK BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4209, -4222, -4225 AND -4226 AND ACHTUNG BLOOD GLUCOSE MONITORING 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 2008-04-02 under 510(k) number K073494. 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 CLEVER CHEK BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4209, -4222, -4225 AND -4226 AND ACHTUNG BLOOD GLUCOSE MONITORING?

CLEVER CHEK BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4209, -4222, -4225 AND -4226 AND ACHTUNG BLOOD GLUCOSE MONITORING is a medical device that received FDA 510(k) clearance on 2008-04-02. The listed applicant is Taidoc Technology Corporation. The 510(k) number is K073494.

When did CLEVER CHEK BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4209, -4222, -4225 AND -4226 AND ACHTUNG BLOOD GLUCOSE MONITORING receive FDA 510(k) clearance?

CLEVER CHEK BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4209, -4222, -4225 AND -4226 AND ACHTUNG BLOOD GLUCOSE MONITORING received FDA 510(k) clearance on 2008-04-02, under 510(k) number K073494.

Who is the listed applicant for CLEVER CHEK BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4209, -4222, -4225 AND -4226 AND ACHTUNG BLOOD GLUCOSE MONITORING?

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 CLEVER CHEK BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4209, -4222, -4225 AND -4226 AND ACHTUNG BLOOD GLUCOSE MONITORING?

The FDA product code for CLEVER CHEK BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4209, -4222, -4225 AND -4226 AND ACHTUNG BLOOD GLUCOSE MONITORING 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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