| 510(k) Number |
K844592 |
| Device Name |
MTA 86 |
| Applicant |
| Madsen Electronics (Canada) , Ltd. |
| 2370 Speers Rd. |
| P.O. Box 535 |
|
Oakville, Ontario,
CA
L6J5B4
|
|
| Applicant Contact |
DAVID E ABRAHAM |
| Correspondent |
| Madsen Electronics (Canada) , Ltd. |
| 2370 Speers Rd. |
| P.O. Box 535 |
|
Oakville, Ontario,
CA
L6J5B4
|
|
| Correspondent Contact |
DAVID E ABRAHAM |
| Date Received | 11/26/1984 |
| Decision Date | 05/22/1985 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Neurology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|