510(k) K211640

Ponto 5 Mini by Oticon Medical AB — Product Code LXB

K211640 is an FDA 510(k) premarket notification submitted by Oticon Medical AB for the device "Ponto 5 Mini". The FDA issued a decision of Substantially Equivalent on August 10, 2021. The device falls under product code LXB (Hearing Aid, Bone Conduction), a Class II device regulated under 21 CFR 874.3302. Oticon Medical AB has at least 10 other 510(k) clearances on record.