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FDA 510(k)

CLEVER CHEK AUTO-CODE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4243

K-Number: K081144 · 2008-06-23

ApplicantTaidoc Technology Corporation
Decision Date2008-06-23
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CLEVER CHEK AUTO-CODE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4243 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 2008-06-23 under 510(k) number K081144. 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 AUTO-CODE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4243?

CLEVER CHEK AUTO-CODE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4243 is a medical device that received FDA 510(k) clearance on 2008-06-23. The listed applicant is Taidoc Technology Corporation. The 510(k) number is K081144.

When did CLEVER CHEK AUTO-CODE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4243 receive FDA 510(k) clearance?

CLEVER CHEK AUTO-CODE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4243 received FDA 510(k) clearance on 2008-06-23, under 510(k) number K081144.

Who is the listed applicant for CLEVER CHEK AUTO-CODE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4243?

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 AUTO-CODE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4243?

The FDA product code for CLEVER CHEK AUTO-CODE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4243 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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