FLAATZ 760


Device Classification Name

system, x-ray, stationary

510(k) Number K111655
Device Name FLAATZ 760
Applicant
DRTECH CORP.
333-1, sangdeawon 1-dong
jungwon-gu
seongnam-shi, gyeonggi-do, 

KR

462-807

Applicant Contact choul-woo shin
Correspondent
DRTECH CORP.
333-1, sangdeawon 1-dong
jungwon-gu
seongnam-shi, gyeonggi-do, 

KR

462-807

Correspodent Contact choul-woo shin
Regulation Number 892.1680
Classification Product Code
KPR  
Date Received 06/13/2011
Decision Date 11/30/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No