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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, Bone Conduction
510(k) Number K123962
Device Name OTOMAG BONE CONDUCTION HEARING SYSTEM
Applicant
Sophono, Inc.
5744 Central Ave. #100
Boulder,  CO  80301
Applicant Contact KRISTA B TRAYNOR
Correspondent
Sophono, Inc.
5744 Central Ave. #100
Boulder,  CO  80301
Correspondent Contact KRISTA B TRAYNOR
Regulation Number874.3302
Classification Product Code
LXB  
Date Received12/26/2012
Decision Date 04/08/2013
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
Predetermined Change
Control Plan Authorized		 No
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