FDA 510(k)

HEALTHPRO BLOOD GLUCOSE MONITORING SYSTEM

K-Number: K113192 · 2012-07-13

Decision Date2012-07-13

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

HEALTHPRO BLOOD GLUCOSE MONITORING 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 2012-07-13 under 510(k) number K113192. 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 HEALTHPRO BLOOD GLUCOSE MONITORING SYSTEM?

HEALTHPRO BLOOD GLUCOSE MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2012-07-13. The listed applicant is Infopia Co, Ltd.. The 510(k) number is K113192.

When did HEALTHPRO BLOOD GLUCOSE MONITORING SYSTEM receive FDA 510(k) clearance?

HEALTHPRO BLOOD GLUCOSE MONITORING SYSTEM received FDA 510(k) clearance on 2012-07-13, under 510(k) number K113192.

Who is the listed applicant for HEALTHPRO BLOOD GLUCOSE MONITORING 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 HEALTHPRO BLOOD GLUCOSE MONITORING SYSTEM?

The FDA product code for HEALTHPRO BLOOD GLUCOSE MONITORING SYSTEM is NBW. This falls under the OB/GYN category.

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Other records listing Infopia Co, Ltd. as applicant

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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.