Device Classification Name |
Coil, Magnetic Resonance, Specialty
|
510(k) Number |
K001312 |
Device Name |
MODEL 473SI-64E QUADRATURE LOWER EXTREMITY COIL |
Applicant |
IGC-MEDICAL ADVANCES, INC. |
10437 INNOVATION DR. |
MILWAUKEE,
WI
53226
|
|
Applicant Contact |
THOMAS E TYNES |
Correspondent |
IGC-MEDICAL ADVANCES, INC. |
10437 INNOVATION DR. |
MILWAUKEE,
WI
53226
|
|
Correspondent Contact |
THOMAS E TYNES |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 04/26/2000 |
Decision Date | 06/20/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|