SOUNDCURE SERENADE TINNITUS TREATMENT SYSTEM


Device Classification Name

masker, tinnitus

510(k) Number K111293
Device Name SOUNDCURE SERENADE TINNITUS TREATMENT SYSTEM
Applicant
SOUNDCURE INC
560 south winchester blvd
suite 500
san jose, 
CA 
95128

Applicant Contact nancy lince
Correspondent
SOUNDCURE INC
560 south winchester blvd
suite 500
san jose, 
CA 
95128

Correspodent Contact nancy lince
Regulation Number 874.3400
Classification Product Code
KLW  
Date Received 05/06/2011
Decision Date 08/24/2011
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