Device Classification Name |
Electromyograph, Diagnostic
|
510(k) Number |
K031995 |
Device Name |
COMPREHENSIVE NEUROMUSCULAR PROFILER |
Applicant |
MEDICAL TECHNOLOGIES UNLIMITED, INC. |
7538 BEAR CANYON RD. NE |
ALBUQUERQUE,
NM
87109
|
|
Applicant Contact |
ANGELA MORRIS |
Correspondent |
MEDICAL TECHNOLOGIES UNLIMITED, INC. |
7538 BEAR CANYON RD. NE |
ALBUQUERQUE,
NM
87109
|
|
Correspondent Contact |
ANGELA MORRIS |
Regulation Number | 890.1375
|
Classification Product Code |
|
Date Received | 06/27/2003 |
Decision Date | 01/07/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|