510(k) K072369

EVOLUTION BLOOD GLUCOSE MONITORING SYSTEM by Hmd Biomedical, LLC — Product Code NBW

K072369 is an FDA 510(k) premarket notification submitted by Hmd Biomedical, LLC for the device "EVOLUTION BLOOD GLUCOSE MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on March 21, 2008. The device falls under product code NBW (System, Test, Blood Glucose, Over The Counter), a Class II device regulated under 21 CFR 862.1345. Hmd Biomedical, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 2008
Date Received
August 23, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Blood Glucose, Over The Counter
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type