| 510(k) Number |
K852034 |
| Device Name |
VITATRON M |
| Applicant |
| Elmed, Inc. |
| 60 W. Fay Ave. |
|
Addison,
IL
60101
|
|
| Applicant Contact |
KARL HAUSNER |
| Correspondent |
| Elmed, Inc. |
| 60 W. Fay Ave. |
|
Addison,
IL
60101
|
|
| Correspondent Contact |
KARL HAUSNER |
| Date Received | 05/09/1985 |
| Decision Date | 01/03/1986 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Physical Medicine
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|