FDA 510(k)

ARKRAY DIABETES DATA MANAGEMENT SOFTWARE (SMBG VIEWER)

K-Number: K093819 · 2010-06-09

Decision Date2010-06-09

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

ARKRAY DIABETES DATA MANAGEMENT SOFTWARE (SMBG VIEWER) 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 2010-06-09 under 510(k) number K093819. 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 ARKRAY DIABETES DATA MANAGEMENT SOFTWARE (SMBG VIEWER)?

ARKRAY DIABETES DATA MANAGEMENT SOFTWARE (SMBG VIEWER) is a medical device that received FDA 510(k) clearance on 2010-06-09. The listed applicant is Arkray Factory USA, Inc.. The 510(k) number is K093819.

When did ARKRAY DIABETES DATA MANAGEMENT SOFTWARE (SMBG VIEWER) receive FDA 510(k) clearance?

ARKRAY DIABETES DATA MANAGEMENT SOFTWARE (SMBG VIEWER) received FDA 510(k) clearance on 2010-06-09, under 510(k) number K093819.

Who is the listed applicant for ARKRAY DIABETES DATA MANAGEMENT SOFTWARE (SMBG VIEWER)?

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 ARKRAY DIABETES DATA MANAGEMENT SOFTWARE (SMBG VIEWER)?

The FDA product code for ARKRAY DIABETES DATA MANAGEMENT SOFTWARE (SMBG VIEWER) is NBW. This falls under the OB/GYN category.

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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.