SOUNDBITE HEARING SYSTEM BY SONITUS MEDICAL


Device Classification Name

hearing aid, bone conduction

510(k) Number K110831
Device Name SOUNDBITE HEARING SYSTEM BY SONITUS MEDICAL
Applicant
SONITUS MEDICAL INC
25 hartford avenue
san carlos, 
CA 
94070

Applicant Contact robert j chin, ph.d.
Correspondent
SONITUS MEDICAL INC
25 hartford avenue
san carlos, 
CA 
94070

Correspodent Contact robert j chin, ph.d.
Regulation Number 874.3300
Classification Product Code
LXB  
Date Received 03/25/2011
Decision Date 06/21/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ear Nose & Throat

510k Review Panel

Ear Nose & Throat

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls