| Device Classification Name |
Device, Biofeedback
|
| 510(k) Number |
K920038 |
| Device Name |
NEUROSEARCH-4 |
| Applicant |
| Lexicor |
| 2585 Central Ave. |
|
Boulder,
CO
80301
|
|
| Applicant Contact |
KENNETH NICHOLS |
| Correspondent |
| Lexicor |
| 2585 Central Ave. |
|
Boulder,
CO
80301
|
|
| Correspondent Contact |
KENNETH NICHOLS |
| Regulation Number | 882.5050 |
| Classification Product Code |
|
| Subsequent Product Codes |
|
| Date Received | 01/06/1992 |
| Decision Date | 02/08/1995 |
| 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
|
|
|