Device Classification Name |
System, X-Ray, Stationary
|
510(k) Number |
K122589 |
Device Name |
DFP4343C7 |
Applicant |
MDI CONSULTANTS, INC. |
55 NORTHERN BOULEVARD |
SUITE 200 |
GREAT NECK,
NY
11021
|
|
Applicant Contact |
JIGAR SHAH |
Correspondent |
MDI CONSULTANTS, INC. |
55 NORTHERN BOULEVARD |
SUITE 200 |
GREAT NECK,
NY
11021
|
|
Correspondent Contact |
JIGAR SHAH |
Regulation Number | 892.1680
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/24/2012 |
Decision Date | 10/05/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|