IE-ZEN (IN CLEAR SERIES HEARING AID)


Device Classification Name

masker, tinnitus

510(k) Number K110973
Device Name IE-ZEN (IN CLEAR SERIES HEARING AID)
Applicant
WIDEX USA
2300 cabot drive, suite 415
lisle, 
IL 
60532

Applicant Contact francis kuk
Correspondent
WIDEX USA
2300 cabot drive, suite 415
lisle, 
IL 
60532

Correspodent Contact francis kuk
Regulation Number 874.3400
Classification Product Code
KLW  
Date Received 04/06/2011
Decision Date 05/05/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ear Nose & Throat

510k Review Panel

Ear Nose & Throat

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No