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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 K161671
Device Name Ponto 3, Ponto 3 Power and Ponto 3 SuperPower
Applicant
Oticon Medical AB
Datavagen 37b
Askim,  SE SE-436 32
Applicant Contact Satu Hjartstam
Correspondent
Oticon Medical AB
Datavagen 37b
Askim,  SE SE-436 32
Correspondent Contact Satu Hjartstam
Regulation Number874.3302
Classification Product Code
LXB  
Subsequent Product Codes
ESD   MAH  
Date Received06/16/2016
Decision Date 09/29/2016
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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