Device Classification Name |
Stimulator, Photic, Evoked Response
|
510(k) Number |
K834442 |
Device Name |
LED STIMULATOR LS-05 |
Applicant |
TECA, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
TECA, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 882.1890
|
Classification Product Code |
|
Date Received | 12/16/1983 |
Decision Date | 08/08/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|