510(k) K190540

Ponto 4 by Oticon Medical AB — Product Code LXB

K190540 is an FDA 510(k) premarket notification submitted by Oticon Medical AB for the device "Ponto 4". The FDA issued a decision of Substantially Equivalent on May 2, 2019. 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.