FDA 510(k)

GLUCOCARD X-METER BLOOD GLUCOSE MONITORING SYSTEM

K-Number: K063771 · 2007-08-09

Decision Date2007-08-09

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

GLUCOCARD X-METER BLOOD GLUCOSE MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Arkray Factory USA, Inc.. It received FDA 510(k) clearance on 2007-08-09 under 510(k) number K063771. 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 GLUCOCARD X-METER BLOOD GLUCOSE MONITORING SYSTEM?

GLUCOCARD X-METER BLOOD GLUCOSE MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2007-08-09. The listed applicant is Arkray Factory USA, Inc.. The 510(k) number is K063771.

When did GLUCOCARD X-METER BLOOD GLUCOSE MONITORING SYSTEM receive FDA 510(k) clearance?

GLUCOCARD X-METER BLOOD GLUCOSE MONITORING SYSTEM received FDA 510(k) clearance on 2007-08-09, under 510(k) number K063771.

Who is the listed applicant for GLUCOCARD X-METER BLOOD GLUCOSE MONITORING SYSTEM?

The FDA 510(k) record lists Arkray Factory USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GLUCOCARD X-METER BLOOD GLUCOSE MONITORING SYSTEM?

The FDA product code for GLUCOCARD X-METER BLOOD GLUCOSE MONITORING 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.