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FDA 510(k)

SURECHEK EDGE BLOOD GLUCOSE MONITORING SYSTEM, MODEL SMS-4240

K-Number: K080501 · 2008-04-21

ApplicantTaidoc Technology Corporation
Decision Date2008-04-21
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SURECHEK EDGE BLOOD GLUCOSE MONITORING SYSTEM, MODEL SMS-4240 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 2008-04-21 under 510(k) number K080501. 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 SURECHEK EDGE BLOOD GLUCOSE MONITORING SYSTEM, MODEL SMS-4240?

SURECHEK EDGE BLOOD GLUCOSE MONITORING SYSTEM, MODEL SMS-4240 is a medical device that received FDA 510(k) clearance on 2008-04-21. The listed applicant is Taidoc Technology Corporation. The 510(k) number is K080501.

When did SURECHEK EDGE BLOOD GLUCOSE MONITORING SYSTEM, MODEL SMS-4240 receive FDA 510(k) clearance?

SURECHEK EDGE BLOOD GLUCOSE MONITORING SYSTEM, MODEL SMS-4240 received FDA 510(k) clearance on 2008-04-21, under 510(k) number K080501.

Who is the listed applicant for SURECHEK EDGE BLOOD GLUCOSE MONITORING SYSTEM, MODEL SMS-4240?

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 SURECHEK EDGE BLOOD GLUCOSE MONITORING SYSTEM, MODEL SMS-4240?

The FDA product code for SURECHEK EDGE BLOOD GLUCOSE MONITORING SYSTEM, MODEL SMS-4240 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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