GN OTOMETRICS INSERT EARPHONES


Device Classification Name

audiometer

510(k) Number K081234
Device Name GN OTOMETRICS INSERT EARPHONES
Applicant
GN OTOMETRICS
125 e. commerce drive
schaumburg, 
IL 
60173

Applicant Contact daniel sansonetti
Correspondent
GN OTOMETRICS
125 e. commerce drive
schaumburg, 
IL 
60173

Correspodent Contact daniel sansonetti
Regulation Number 874.1050
Classification Product Code
EWO  
Date Received 05/01/2008
Decision Date 07/14/2008
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