FDA 510(k)

GLUCO LAB AUTO CODING, MODEL IGM-0022

K-Number: K091157 · 2009-11-17

Decision Date2009-11-17

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

GLUCO LAB AUTO CODING, MODEL IGM-0022 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 2009-11-17 under 510(k) number K091157. 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 GLUCO LAB AUTO CODING, MODEL IGM-0022?

GLUCO LAB AUTO CODING, MODEL IGM-0022 is a medical device that received FDA 510(k) clearance on 2009-11-17. The listed applicant is Infopia Co, Ltd.. The 510(k) number is K091157.

When did GLUCO LAB AUTO CODING, MODEL IGM-0022 receive FDA 510(k) clearance?

GLUCO LAB AUTO CODING, MODEL IGM-0022 received FDA 510(k) clearance on 2009-11-17, under 510(k) number K091157.

Who is the listed applicant for GLUCO LAB AUTO CODING, MODEL IGM-0022?

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 GLUCO LAB AUTO CODING, MODEL IGM-0022?

The FDA product code for GLUCO LAB AUTO CODING, MODEL IGM-0022 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.