INSOUND XT SERIES HEARING AID


Device Classification Name

hearing aid, air conduction

510(k) Number K021867
Device Name INSOUND XT SERIES HEARING AID
Original Applicant
INSOUND MEDICAL INC.
37500 central court
newark, 
CA 
94560

Original Contact susan whichard
Regulation Number 874.3300
Classification Product Code
ESD  
Date Received 06/06/2002
Decision Date 11/19/2002
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