| Device Classification Name |
Stimulator, Electrical, Evoked Response
|
| 510(k) Number |
K843464 |
| Device Name |
SIEGEN NEUROSCOPE |
| Applicant |
| Siegen Corp. |
| 2450 Bayshore Frontage Rd. |
|
Mountain View ,
CA
94043 -
|
|
| Applicant Contact |
CAPERS W MCDONALD |
| Correspondent |
| Siegen Corp. |
| 2450 Bayshore Frontage Rd. |
|
Mountain View ,
CA
94043 -
|
|
| Correspondent Contact |
CAPERS W MCDONALD |
| Regulation Number | 882.1870 |
| Classification Product Code |
|
| Date Received | 09/05/1984 |
| Decision Date | 11/20/1984 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Neurology
|
| 510k Review Panel |
Neurology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|