Device Classification Name |
Stimulator, Auditory, Evoked Response
|
510(k) Number |
K043396 |
Device Name |
INTEGRITY, MODEL V500 |
Applicant |
VIVOSONIC, INC. |
56 ABERFOYLE CRESCENT |
SUITE 620 |
TORONTO, ON,
CA
M8X 2W4
|
|
Applicant Contact |
EDWARD GOSS |
Correspondent |
ENTELA, INC. |
3033 MADISON AVENUE, SE |
GRAND RAPIDS,
MI
49548
|
|
Correspondent Contact |
N.E. DEVINE |
Regulation Number | 882.1900
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/10/2004 |
Decision Date | 01/24/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|