510(k) K121228

PONTO BONE ANCHORED HEARING SYSTEM by Oticon Medical AB — Product Code MAH

K121228 is an FDA 510(k) premarket notification submitted by Oticon Medical AB for the device "PONTO BONE ANCHORED HEARING SYSTEM". The FDA issued a decision of Substantially Equivalent on September 7, 2012. 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.