FDA 510(k)

ARK CARE DIABETES MANAGMENT SYSTEM

K-Number: K110709 · 2011-05-19

Decision Date2011-05-19

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

ARK CARE DIABETES MANAGMENT 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 2011-05-19 under 510(k) number K110709. 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 ARK CARE DIABETES MANAGMENT SYSTEM?

ARK CARE DIABETES MANAGMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2011-05-19. The listed applicant is Arkray Factory USA, Inc.. The 510(k) number is K110709.

When did ARK CARE DIABETES MANAGMENT SYSTEM receive FDA 510(k) clearance?

ARK CARE DIABETES MANAGMENT SYSTEM received FDA 510(k) clearance on 2011-05-19, under 510(k) number K110709.

Who is the listed applicant for ARK CARE DIABETES MANAGMENT 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 ARK CARE DIABETES MANAGMENT SYSTEM?

The FDA product code for ARK CARE DIABETES MANAGMENT SYSTEM 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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.