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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Audiometer
510(k) Number K151025
Device Name iHearTest
Applicant
IHEAR MEDICAL, INC.
15250 HESPERIAN BLVD, STE #102
SAN LEANDRO,  CA  94578
Applicant Contact ANGELA LEE FOREMAN
Correspondent
IHEAR MEDICAL, INC.
15250 HESPERIAN BLVD, STE #102
SAN LEANDRO,  CA  94578
Correspondent Contact ANGELA LEE FOREMAN
Regulation Number874.1050
Classification Product Code
EWO  
Date Received04/16/2015
Decision Date 12/29/2015
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
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