ASCENSIA BREEZE BLOOD GLUCOSE METER


Device Classification Name

glucose oxidase, glucose

510(k) Number K024062
Device Name ASCENSIA BREEZE BLOOD GLUCOSE METER
Original Applicant
BAYER CORP.
1884 miles ave.
p.o. box 70
elkhart, 
IN 
46515 -0070

Original Contact george m tancos
Regulation Number 862.1345
Classification Product Code
CGA  
Subsequent Product Code
NBW  
Date Received 12/09/2002
Decision Date 03/03/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No