FLAATZ 750


Device Classification Name

solid state x-ray imager (flat panel/digital imager)

510(k) Number K080064
Device Name FLAATZ 750
Applicant
DRTECH CORP.
333-1, sangdeawon 1-dong
jungwon-gu
seongnam-shi, gyeonggi-do, 

KR

462-807

Applicant Contact beom-jin moon
Regulation Number 892.1680
Classification Product Code
MQB  
Date Received 01/10/2008
Decision Date 01/23/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

statement

statement

Type Traditional
Reviewed by Third Party Yes

Combination Product

No