Device Classification Name |
electromyograph, diagnostic
|
510(k) Number |
K142494 |
FOIA Releasable 510(k) |
K142494
|
Device Name |
ViMove |
Applicant |
dorsaVi Ltd. |
Level 1, 120 Jolimont Road |
East Melbourne,
AU
3002
|
|
Applicant Contact |
Dan Ronchi |
Correspondent |
MJ RAC |
1208-12 Rockford Rd. |
Toronto,
CA
M2R 3A2
|
|
Correspondent Contact |
Bosmat Friedman |
Regulation Number | 890.1375
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/05/2014 |
Decision Date | 05/28/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|