Device Classification Name |
Electrode, Needle, Diagnostic Electromyograph
|
510(k) Number |
K895460 |
Device Name |
CONCENTRIC ELECTRODE TYPE #13R01, 13R02 |
Applicant |
DANTEC ELECTRONICS, INC. |
6 PEARL COURT |
ALLENDALE,
NJ
07401
|
|
Applicant Contact |
JAMES T QUIGLEY |
Correspondent |
DANTEC ELECTRONICS, INC. |
6 PEARL COURT |
ALLENDALE,
NJ
07401
|
|
Correspondent Contact |
JAMES T QUIGLEY |
Regulation Number | 890.1385
|
Classification Product Code |
|
Date Received | 09/06/1989 |
Decision Date | 06/18/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|