Device Classification Name |
Coil, Magnetic Resonance, Specialty
|
510(k) Number |
K003340 |
Device Name |
OBC-149 BREAST 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 | 10/25/2000 |
Decision Date | 11/08/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|