FDA 510(k)

SOLUSMOBILE BLOOD GLUCOSE MANAGMENT SYSTEM

K-Number: K123559 · 2013-06-28

Decision Date2013-06-28

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

SOLUSMOBILE BLOOD GLUCOSE MANAGMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Biotest Medical Corp.. It received FDA 510(k) clearance on 2013-06-28 under 510(k) number K123559. 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 SOLUSMOBILE BLOOD GLUCOSE MANAGMENT SYSTEM?

SOLUSMOBILE BLOOD GLUCOSE MANAGMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2013-06-28. The listed applicant is Biotest Medical Corp.. The 510(k) number is K123559.

When did SOLUSMOBILE BLOOD GLUCOSE MANAGMENT SYSTEM receive FDA 510(k) clearance?

SOLUSMOBILE BLOOD GLUCOSE MANAGMENT SYSTEM received FDA 510(k) clearance on 2013-06-28, under 510(k) number K123559.

Who is the listed applicant for SOLUSMOBILE BLOOD GLUCOSE MANAGMENT SYSTEM?

The FDA 510(k) record lists Biotest Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOLUSMOBILE BLOOD GLUCOSE MANAGMENT SYSTEM?

The FDA product code for SOLUSMOBILE BLOOD GLUCOSE MANAGMENT SYSTEM is NBW. This falls under the OB/GYN category.

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Other records listing Biotest Medical Corp. as applicant

K122525SMARTEST GLUCOWISE BLOOD GLUCOSE MONITORING SYSTEM, AND SMARTEST GLUCOSWISE MULTI BLOOD GLUCOSE MONITORING SYSTEM K100560EASY TALK BLOOD GLUCOSE MONITORING SYSTEM MODEL: 6277 K100701SMARTEST PERSONA BLOOD GLUCOSE TEST SYTEM MODEL: 6277 K093764SOLOV2 BLOOD GLUCOSE MONITORING SYSTEM K091815SUPERCHECK 1 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 6268

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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.