Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K140869 |
Device Name |
DCAS I |
Applicant |
GP&P CO., LTD. |
12226 WASHINGTON LANE |
PARKER,
AZ
85344
|
|
Applicant Contact |
CHARLIE MACK |
Correspondent |
GP&P CO., LTD. |
12226 WASHINGTON LANE |
PARKER,
AZ
85344
|
|
Correspondent Contact |
CHARLIE MACK |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 04/03/2014 |
Decision Date | 07/03/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|