Device Classification Name |
Electrode, Needle, Diagnostic Electromyograph
|
510(k) Number |
K961013 |
Device Name |
DISPOSABLE NEEDLE ELECTRODE |
Applicant |
MEDELEC INTL. CORP. |
MANOR WAY |
OLD WOKING, SURREY GU22 9JU |
ENGLAND,
GB
|
|
Applicant Contact |
JEFF HALL |
Correspondent |
MEDELEC INTL. CORP. |
MANOR WAY |
OLD WOKING, SURREY GU22 9JU |
ENGLAND,
GB
|
|
Correspondent Contact |
JEFF HALL |
Regulation Number | 890.1385
|
Classification Product Code |
|
Date Received | 03/13/1996 |
Decision Date | 12/20/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|