Device Classification Name |
Stimulator, Electrical, Evoked Response
|
510(k) Number |
K843712 |
Device Name |
AUDIT TM V |
Applicant |
AXONICS, INC. |
1500 SALADO DRIVE |
MOUNTAIN VIEW ,
CA
94043 -
|
|
Applicant Contact |
JOHN LEE |
Correspondent |
AXONICS, INC. |
1500 SALADO DRIVE |
MOUNTAIN VIEW ,
CA
94043 -
|
|
Correspondent Contact |
JOHN LEE |
Regulation Number | 882.1870
|
Classification Product Code |
|
Date Received | 09/21/1984 |
Decision Date | 04/05/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|