Device Classification Name |
Device, Biofeedback
|
510(k) Number |
K960761 |
Device Name |
PATHWAY ELECTROMYOGRAPH MODEL TR-10 & TR-20 |
Applicant |
THE PROMETHEUS GROUP |
2 MALLARDS COVE |
DUXBURY,
MA
02332
|
|
Applicant Contact |
PETER A SULLIVAN |
Correspondent |
THE PROMETHEUS GROUP |
2 MALLARDS COVE |
DUXBURY,
MA
02332
|
|
Correspondent Contact |
PETER A SULLIVAN |
Regulation Number | 882.5050
|
Classification Product Code |
|
Date Received | 02/26/1996 |
Decision Date | 08/07/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|