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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 K132775
Device Name PONTO PLUS AND PONTO PLUS POWER
Applicant
Oticon Medical AB
Ekonomivagen 2
Askim,  SE SE-436 33
Applicant Contact SATU HJARTSTAM
Correspondent
Oticon Medical AB
Ekonomivagen 2
Askim,  SE SE-436 33
Correspondent Contact SATU HJARTSTAM
Regulation Number874.3302
Classification Product Code
LXB  
Date Received09/05/2013
Decision Date 12/09/2013
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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