Device Classification Name |
audiometer
|
510(k) Number |
K822335 |
Device Name |
AUDIT |
Applicant |
AXONICS, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
AXONICS, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 874.1050
|
Classification Product Code |
|
Date Received | 08/04/1982 |
Decision Date | 02/07/1983 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|