Device Classification Name |
System, Nuclear Magnetic Resonance Imaging
|
510(k) Number |
K915260 |
Device Name |
MRI ULTRAVIEW |
Applicant |
A&E SPECIALTY FABRICATORS |
24854 FREEDOM COURT |
MORENO VALLEY,
CA
92387
|
|
Applicant Contact |
ANDREW W HICE |
Correspondent |
A&E SPECIALTY FABRICATORS |
24854 FREEDOM COURT |
MORENO VALLEY,
CA
92387
|
|
Correspondent Contact |
ANDREW W HICE |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 11/19/1991 |
Decision Date | 03/16/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|