FDA 510(k)

GLUCOPHONE BLOOD GLUCOSE TEST SYSTEM, MODEL IGM-0025

K-Number: K091168 · 2010-05-27

Decision Date2010-05-27

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

GLUCOPHONE BLOOD GLUCOSE TEST SYSTEM, MODEL IGM-0025 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 2010-05-27 under 510(k) number K091168. 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 GLUCOPHONE BLOOD GLUCOSE TEST SYSTEM, MODEL IGM-0025?

GLUCOPHONE BLOOD GLUCOSE TEST SYSTEM, MODEL IGM-0025 is a medical device that received FDA 510(k) clearance on 2010-05-27. The listed applicant is Infopia Co, Ltd.. The 510(k) number is K091168.

When did GLUCOPHONE BLOOD GLUCOSE TEST SYSTEM, MODEL IGM-0025 receive FDA 510(k) clearance?

GLUCOPHONE BLOOD GLUCOSE TEST SYSTEM, MODEL IGM-0025 received FDA 510(k) clearance on 2010-05-27, under 510(k) number K091168.

Who is the listed applicant for GLUCOPHONE BLOOD GLUCOSE TEST SYSTEM, MODEL IGM-0025?

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 GLUCOPHONE BLOOD GLUCOSE TEST SYSTEM, MODEL IGM-0025?

The FDA product code for GLUCOPHONE BLOOD GLUCOSE TEST SYSTEM, MODEL IGM-0025 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.