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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hearing Aid, Air-Conduction, Prescription
510(k) Number K873800
Device Name INTERNATIONAL MODEL XM BEHIND-THE-EAR
Applicant
INT'L HEARING AIDS, INC.
P.O. BOX 255
HOPKINS,  MN  55343
Applicant Contact BONNIE L SCHEIL
Correspondent
INT'L HEARING AIDS, INC.
P.O. BOX 255
HOPKINS,  MN  55343
Correspondent Contact BONNIE L SCHEIL
Regulation Number874.3300
Classification Product Code
ESD  
Date Received09/18/1987
Decision Date 10/20/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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