Device Classification Name |
stimulator, electrical, evoked response
|
510(k) Number |
K896567 |
Device Name |
CANTATA EMG/EVOKED RESPONSE SYSTEM |
Applicant |
DANTEC MEDICAL, INC. |
777 CORPORATE DR. |
MAHWAH,
NJ
07430
|
|
Applicant Contact |
JAMES T QUIGLEY |
Correspondent |
DANTEC MEDICAL, INC. |
777 CORPORATE DR. |
MAHWAH,
NJ
07430
|
|
Correspondent Contact |
JAMES T QUIGLEY |
Regulation Number | 882.1870
|
Classification Product Code |
|
Date Received | 11/20/1989 |
Decision Date | 02/16/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|