MEDISIGN BLOOD GLUCOSE MONITORING SYSTEM


Device Classification Name

system, test, blood glucose, over the counter

510(k) Number K111456
Device Name MEDISIGN BLOOD GLUCOSE MONITORING SYSTEM
Applicant
TIANJIN EMPECS MEDICAL DEVICE CO., LTD.
rm 1301, gyeonggi vent. anyang
sci univ., 572-5 anyang 8-dong
manan-gu anyang-si gyeonggi-do, 

KR

430-731

Applicant Contact hl jung
Correspondent
TIANJIN EMPECS MEDICAL DEVICE CO., LTD.
rm 1301, gyeonggi vent. anyang
sci univ., 572-5 anyang 8-dong
manan-gu anyang-si gyeonggi-do, 

KR

430-731

Correspodent Contact hl jung
Regulation Number 862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   JJX  
Date Received 05/25/2011
Decision Date 02/28/2012
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