ZEN PROGRAM (MIND 440 HEARING AID)


Device Classification Name

masker, tinnitus

510(k) Number K080955
Device Name ZEN PROGRAM (MIND 440 HEARING AID)
Applicant
WIDEX HEARING AID CO., INC.
2300 cabot drive
suite 415
lisle, 
IL 
60532

Applicant Contact francis kuk
Correspondent
WIDEX HEARING AID CO., INC.
2300 cabot drive
suite 415
lisle, 
IL 
60532

Correspodent Contact francis kuk
Regulation Number 874.3400
Classification Product Code
KLW  
Date Received 04/03/2008
Decision Date 06/27/2008
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