| Device Classification Name |
System, Nuclear Magnetic Resonance Imaging
|
| 510(k) Number |
K903753 |
| Device Name |
CAT. #6000-21 VOLUME NECK COIL, MODIFIED |
| Applicant |
| Medical Advances, Inc. |
| 10431 W. Watertown Plank Rd. |
| P.O. Box 26425 |
|
Milwaukee,
WI
53226
|
|
| Applicant Contact |
WILLIAM L ZABRISKIE |
| Correspondent |
| Medical Advances, Inc. |
| 10431 W. Watertown Plank Rd. |
| P.O. Box 26425 |
|
Milwaukee,
WI
53226
|
|
| Correspondent Contact |
WILLIAM L ZABRISKIE |
| Regulation Number | 892.1000 |
| Classification Product Code |
|
| Date Received | 07/24/1990 |
| Decision Date | 10/26/1990 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Radiology
|
| 510k Review Panel |
Radiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|