Device Classification Name |
System, Nuclear Magnetic Resonance Imaging
|
510(k) Number |
K931656 |
Device Name |
MERIT |
Applicant |
PICKER INTERNATIONAL |
5500 AVION PARK DR. |
HIGHLAND HEIGHTS,
OH
44143
|
|
Applicant Contact |
ULLA TERVONEN |
Correspondent |
PICKER INTERNATIONAL |
5500 AVION PARK DR. |
HIGHLAND HEIGHTS,
OH
44143
|
|
Correspondent Contact |
ULLA TERVONEN |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 04/05/1993 |
Decision Date | 12/14/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|