510(k) K203807

Ponto Bone Anchored Hearing System, MONO Surgery Kit by Oticon Medical AB — Product Code MAH

K203807 is an FDA 510(k) premarket notification submitted by Oticon Medical AB for the device "Ponto Bone Anchored Hearing System, MONO Surgery Kit". The FDA issued a decision of Substantially Equivalent on March 3, 2021. The device falls under product code MAH (Hearing Aid, Bone Conduction, Implanted), a Class II device regulated under 21 CFR 874.3302. Oticon Medical AB has at least 10 other 510(k) clearances on record.