AURICAL HIT


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

Correspodent Contact daniel kamm
Regulation Number 874.3310
Classification Product Code
ETW  
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