Device Classification Name |
Electrode, Needle, Diagnostic Electromyograph
|
510(k) Number |
K973529 |
Device Name |
NEUROLINE, DISPOSABLE CONCENTRIC NEEDLE ELECTRODES |
Applicant |
MEDICOTEST A/S |
1900 K ST. N.W. |
WASHINGTON,
DC
20006 -1108
|
|
Applicant Contact |
EMALEE G MURPHY |
Correspondent |
MEDICOTEST A/S |
1900 K ST. N.W. |
WASHINGTON,
DC
20006 -1108
|
|
Correspondent Contact |
EMALEE G MURPHY |
Regulation Number | 890.1385
|
Classification Product Code |
|
Date Received | 09/18/1997 |
Decision Date | 11/20/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Neurology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|