Device Classification Name |
system, nuclear magnetic resonance imaging
|
510(k) Number |
K883621 |
Device Name |
INSTRUMENTARIUM ULF MR IMAGING SYSTEM |
Applicant |
INSTRUMENTARIUM CORP. |
HYMAN, PHELPS & MCNAMARA, P.C. |
1120 G STREET, N.W. |
WASHINGTON,
DC
20005
|
|
Applicant Contact |
ROBERT DORMER |
Correspondent |
INSTRUMENTARIUM CORP. |
HYMAN, PHELPS & MCNAMARA, P.C. |
1120 G STREET, N.W. |
WASHINGTON,
DC
20005
|
|
Correspondent Contact |
ROBERT DORMER |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 08/25/1988 |
Decision Date | 11/10/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|