Device Classification Name |
coil, magnetic resonance, specialty
|
510(k) Number |
K040349 |
Device Name |
MODIFICATION TO HRW-127 WRIST ARRAY COIL |
Applicant |
MRI DEVICES CORP. |
1515 PARAMOUNT DR. |
WAUKESHA,
WI
53186
|
|
Applicant Contact |
THOMAS SCHUBERT |
Correspondent |
MRI DEVICES CORP. |
1515 PARAMOUNT DR. |
WAUKESHA,
WI
53186
|
|
Correspondent Contact |
THOMAS SCHUBERT |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 02/12/2004 |
Decision Date | 03/09/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|