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 |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
333 PFINGSTEN RD. |
NORTHBROOK,
IL
60062
|
|
Correspondent Contact |
NED DEVINE |
Regulation Number | 892.1680
|
Classification Product Code |
|
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
|
|
|