Device Classification Name |
system, nuclear magnetic resonance imaging
|
510(k) Number |
K883622 |
Device Name |
INSTRUMENTARIUM ULF MR IMAGING SYSTEM |
Applicant |
INSTRUMENTARIUM CORP. |
C/O BIOMETRIC RESEARCH INSTITU |
1401 WILSON BLVD., SUITE 400 |
ARLINGTON,
VA
22209
|
|
Applicant Contact |
FRANK L HURLEY |
Correspondent |
INSTRUMENTARIUM CORP. |
C/O BIOMETRIC RESEARCH INSTITU |
1401 WILSON BLVD., SUITE 400 |
ARLINGTON,
VA
22209
|
|
Correspondent Contact |
FRANK L HURLEY |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 08/25/1988 |
Decision Date | 09/14/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|