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FDA 510(k)

FERRARA BLOOD GLUCOSE MONITORING SYSTEM, MODEL 631100

K-Number: K063068 · 2006-12-20

ApplicantArkray USA, Inc.
Decision Date2006-12-20
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FERRARA BLOOD GLUCOSE MONITORING SYSTEM, MODEL 631100 is the device name listed in this FDA 510(k) record. The listed applicant is Arkray USA, Inc.. It received FDA 510(k) clearance on 2006-12-20 under 510(k) number K063068. 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 FERRARA BLOOD GLUCOSE MONITORING SYSTEM, MODEL 631100?

FERRARA BLOOD GLUCOSE MONITORING SYSTEM, MODEL 631100 is a medical device that received FDA 510(k) clearance on 2006-12-20. The listed applicant is Arkray USA, Inc.. The 510(k) number is K063068.

When did FERRARA BLOOD GLUCOSE MONITORING SYSTEM, MODEL 631100 receive FDA 510(k) clearance?

FERRARA BLOOD GLUCOSE MONITORING SYSTEM, MODEL 631100 received FDA 510(k) clearance on 2006-12-20, under 510(k) number K063068.

Who is the listed applicant for FERRARA BLOOD GLUCOSE MONITORING SYSTEM, MODEL 631100?

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

What is the FDA product code for FERRARA BLOOD GLUCOSE MONITORING SYSTEM, MODEL 631100?

The FDA product code for FERRARA BLOOD GLUCOSE MONITORING SYSTEM, MODEL 631100 is NBW. This falls under the OB/GYN category.

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Official Source

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