Device Classification Name |
Nystagmograph
|
510(k) Number |
K842886 |
Device Name |
TECA MS-20 MYSTRO ELECTROPHYSIOLOGICAL |
Applicant |
TECA, INC. |
THREE CAMPUS DR. |
PLEASANTIVILLE,
NY
10570
|
|
Applicant Contact |
EDWARD SIROIS |
Correspondent |
TECA, INC. |
THREE CAMPUS DR. |
PLEASANTIVILLE,
NY
10570
|
|
Correspondent Contact |
EDWARD SIROIS |
Regulation Number | 882.1460
|
Classification Product Code |
|
Date Received | 07/23/1984 |
Decision Date | 12/12/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|