CARESENS BLOOD GLUCOSE MONITORING SYSTEM; CARESENS II METER, MODEL GM505C; CARESENS POP METER, MODEL GM505EA OR GM505EB


Device Classification Name

system, test, blood glucose, over the counter

510(k) Number K080923
Device Name CARESENS BLOOD GLUCOSE MONITORING SYSTEM; CARESENS II METER, MODEL GM505C; CARESENS POP METER, MODEL GM505EA OR GM505EB
Applicant
i-SENS, Inc.
465-6 wolgye-dong, nowon-gu
seoul, 

KR

139-845

Applicant Contact hyun joon oh
Correspondent
i-SENS, Inc.
465-6 wolgye-dong, nowon-gu
seoul, 

KR

139-845

Correspodent Contact hyun joon oh
Regulation Number 862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   JJX  
Date Received 04/02/2008
Decision Date 10/17/2008
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