CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITOR


Device Classification Name

system, test, blood glucose, over the counter

510(k) Number K122370
Device Name CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITOR
Applicant
BAYER HEALTHCARE
430 south beiger street
mishawaka, 
IN 
46544

Applicant Contact roger sonnenburg
Correspondent
BAYER HEALTHCARE
430 south beiger street
mishawaka, 
IN 
46544

Correspodent Contact roger sonnenburg
Regulation Number 862.1345
Classification Product Code
NBW  
Subsequent Product Code
LFR  
Date Received 08/06/2012
Decision Date 09/26/2013
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