FDA 510(k)

ENVISION BLOOD GLUCOSE TEST SYSTEM

K-Number: K082020 · 2008-12-24

Decision Date2008-12-24

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

ENVISION BLOOD GLUCOSE TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Infopia Co, Ltd.. It received FDA 510(k) clearance on 2008-12-24 under 510(k) number K082020. 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 ENVISION BLOOD GLUCOSE TEST SYSTEM?

ENVISION BLOOD GLUCOSE TEST SYSTEM is a medical device that received FDA 510(k) clearance on 2008-12-24. The listed applicant is Infopia Co, Ltd.. The 510(k) number is K082020.

When did ENVISION BLOOD GLUCOSE TEST SYSTEM receive FDA 510(k) clearance?

ENVISION BLOOD GLUCOSE TEST SYSTEM received FDA 510(k) clearance on 2008-12-24, under 510(k) number K082020.

Who is the listed applicant for ENVISION BLOOD GLUCOSE TEST SYSTEM?

The FDA 510(k) record lists Infopia Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENVISION BLOOD GLUCOSE TEST SYSTEM?

The FDA product code for ENVISION BLOOD GLUCOSE TEST SYSTEM 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.