CLEVER CHEK TD-3250C BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM


Device Classification Name

system, test, blood glucose, over the counter

510(k) Number K080014
Device Name CLEVER CHEK TD-3250C BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM
Applicant
TaiDoc Technology Corporation
6f, no. 127, wugong 2nd rd
wugu township
taipei county, 

TW

241

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

TW

241

Correspodent Contact yuhua chen
Regulation Number 862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   DXN  
Date Received 01/03/2008
Decision Date 06/09/2008
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