Device Classification Name |
Electromyograph, Diagnostic
|
510(k) Number |
K113074 |
Device Name |
CMAP PRO |
Applicant |
MEDICAL TECHNOLOGIES, INC. |
5901-J WYOMING NE, |
SUITE 125 |
ALBUQUERQUE,
NM
87106
|
|
Applicant Contact |
ANGELA MORRIS |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
1285 WALT WHITMAN RD. |
MELVILLE,
NY
11747
|
|
Correspondent Contact |
CASEY CONRY |
Regulation Number | 890.1375
|
Classification Product Code |
|
Date Received | 10/17/2011 |
Decision Date | 02/02/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|