EVOLUTION BLOOD GLUCOSE MONITORING SYSTEM


Device Classification Name

system, test, blood glucose, over the counter

510(k) Number K072369
Device Name EVOLUTION BLOOD GLUCOSE MONITORING SYSTEM
Applicant
HMD BIOMEDICAL LLC
8855 grissom parkway
titusville, 
FL 
32780

Applicant Contact merrell shye
Correspondent
HMD BIOMEDICAL LLC
8855 grissom parkway
titusville, 
FL 
32780

Correspodent Contact merrell shye
Regulation Number 862.1345
Classification Product Code
NBW  
Date Received 08/23/2007
Decision Date 03/21/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No