Device Classification Name |
electromyograph, diagnostic
|
510(k) Number |
K131094 |
Device Name |
VIMOVE |
Applicant |
DORSA VI PTY. LTD |
1914 J N PEASE PLACE |
CHARLOTTE,
NC
28262
|
|
Applicant Contact |
SHOSHANA FRIEDMAN |
Correspondent |
DORSA VI PTY. LTD |
1914 J N PEASE PLACE |
CHARLOTTE,
NC
28262
|
|
Correspondent Contact |
SHOSHANA FRIEDMAN |
Regulation Number | 890.1375
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/18/2013 |
Decision Date | 07/11/2014 |
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
|
|
|