PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM


Device Classification Name

devices, breath trapping, alcohol

510(k) Number K110614
Device Name PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM
Applicant
SEJU ENGINEERING CO., LTD.
certification division
d-524 migun techno world2,
yuseong-gu, daejeon, 

KR

305-500

Applicant Contact eileen yang
Correspondent
SEJU ENGINEERING CO., LTD.
certification division
d-524 migun techno world2,
yuseong-gu, daejeon, 

KR

305-500

Correspodent Contact eileen yang
Regulation Number 862.3050
Classification Product Code
DJZ  
Date Received 03/03/2011
Decision Date 11/21/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No