IDEAL LIFE GLUCO-MANAGER GMM 0001 BLOOD GLUCOSE MONITORING SYSTEM


Device Classification Name

system, test, blood glucose, over the counter

510(k) Number K080283
Device Name IDEAL LIFE GLUCO-MANAGER GMM 0001 BLOOD GLUCOSE MONITORING SYSTEM
Applicant
TaiDoc Technology Corporation
6f, no. 127, wugong 2nd rd
wugu township
taipei county, 

TW

248

Applicant Contact yuhua chen
Correspondent
TaiDoc Technology Corporation
6f, no. 127, wugong 2nd rd
wugu township
taipei county, 

TW

248

Correspodent Contact yuhua chen
Regulation Number 862.1345
Classification Product Code
NBW  
Subsequent Product Code
CGA  
Date Received 02/04/2008
Decision Date 06/27/2008
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