GN OTOMETRICS TYPE 1053 FREEFIT


Device Classification Name

calibrator, hearing aid / earphone and analysis systems

510(k) Number K110286
Device Name GN OTOMETRICS TYPE 1053 FREEFIT
Applicant
GN OTOMETRICS A/S
125 commerce drive
schaumburg, 
IL 
60173 -5329

Applicant Contact tom riniker
Regulation Number 874.3310
Classification Product Code
ETW  
Date Received 01/31/2011
Decision Date 04/28/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ear Nose & Throat

510k Review Panel

Ear Nose & Throat

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No