Device Classification Name |
stimulator, photic, evoked response
|
510(k) Number |
K120104 |
Device Name |
VISIONSEARCH 1 |
Applicant |
VISIONSEARCH PTY LTD |
460 PACIFIC HIGHWAY |
SUITE 408 |
ST LEONARDS,
AU
2074
|
|
Applicant Contact |
ARTHUR BRANDWOOD |
Correspondent |
TUV SUD AMERICA INC. |
1775 OLD HIGHWAY 8 NW |
NEW BRIGHTON,
MN
55112 -1891
|
|
Regulation Number | 882.1890
|
Classification Product Code |
|
Date Received | 01/13/2012 |
Decision Date | 05/21/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|