Device Classification Name |
calibrator, hearing aid / earphone and analysis systems
|
510(k) Number |
K122028 |
Device Name |
AURICAL HIT |
Applicant |
GN OTOMETRICS |
8870 RAVELLO CT |
NAPLES,
FL
34114
|
|
Applicant Contact |
DANIEL KAMM |
Correspondent |
GN OTOMETRICS |
8870 RAVELLO CT |
NAPLES,
FL
34114
|
|
Correspondent Contact |
DANIEL KAMM |
Regulation Number | 874.3310
|
Classification Product Code |
|
Date Received | 07/10/2012 |
Decision Date | 10/23/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|