Device Classification Name |
Coil, Magnetic Resonance, Specialty
|
510(k) Number |
K003685 |
Device Name |
MODEL 342GE-64 HIGH RESOLUTION BRAIN COIL |
Applicant |
MEDICAL ADVANCES, INC. |
10437 INNOVATION DR. |
MILWAUKEE,
WI
53226
|
|
Applicant Contact |
MICHAEL LEIGH |
Correspondent |
MEDICAL ADVANCES, INC. |
10437 INNOVATION DR. |
MILWAUKEE,
WI
53226
|
|
Correspondent Contact |
MICHAEL LEIGH |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 11/30/2000 |
Decision Date | 12/22/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|