| Device Classification Name |
System, X-Ray, Tomography, Computed
|
| 510(k) Number |
K970819 |
| Device Name |
TARGOBEAM |
| Applicant |
| Ferguson Medical |
| 3407 Bay Ave. |
|
Chico,
CA
95973
|
|
| Applicant Contact |
FRANK FERGUSON |
| Correspondent |
| Ferguson Medical |
| 3407 Bay Ave. |
|
Chico,
CA
95973
|
|
| Correspondent Contact |
FRANK FERGUSON |
| Regulation Number | 892.1750 |
| Classification Product Code |
|
| Date Received | 03/05/1997 |
| Decision Date | 07/14/1997 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Radiology
|
| 510k Review Panel |
Radiology
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|