FDA 510(k)

ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 46001

K-Number: K090332 · 2009-08-14

Decision Date2009-08-14

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 46001 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 2009-08-14 under 510(k) number K090332. 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 ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 46001?

ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 46001 is a medical device that received FDA 510(k) clearance on 2009-08-14. The listed applicant is Arkray Factory USA, Inc.. The 510(k) number is K090332.

When did ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 46001 receive FDA 510(k) clearance?

ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 46001 received FDA 510(k) clearance on 2009-08-14, under 510(k) number K090332.

Who is the listed applicant for ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 46001?

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 ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 46001?

The FDA product code for ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 46001 is NBW. This falls under the OB/GYN category.

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Other records listing Arkray Factory USA, Inc. 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.