TINNITUS SOUND GENERATOR MODULE


Device Classification Name

masker, tinnitus

510(k) Number K073636
Device Name TINNITUS SOUND GENERATOR MODULE
Applicant
GN RESOUND A/S
lautrupbjerg 7
ballerup, 

DK

dk-2750

Applicant Contact lars hagander
Correspondent
GN RESOUND A/S
lautrupbjerg 7
ballerup, 

DK

dk-2750

Correspodent Contact lars hagander
Regulation Number 874.3400
Classification Product Code
KLW  
Date Received 12/26/2007
Decision Date 03/13/2008
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