REVOLUTION TD-4229 BLOOD GLUCOSE MONITORING SYSTEM


Device Classification Name

system, test, blood glucose, over the counter

510(k) Number K072489
Device Name REVOLUTION TD-4229 BLOOD GLUCOSE MONITORING SYSTEM
Applicant
TaiDoc Technology Corporation
4f, 88, sec.1, kwang fu road
san chung, taipei, 

TW

241

Applicant Contact erica li
Correspondent
TaiDoc Technology Corporation
4f, 88, sec.1, kwang fu road
san chung, taipei, 

TW

241

Correspodent Contact erica li
Regulation Number 862.1345
Classification Product Code
NBW  
Subsequent Product Code
CGA  
Date Received 09/04/2007
Decision Date 09/20/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

statement

statement

FDA Review Decision Summary
Type Special
Reviewed by Third Party No

Combination Product

No