510(k) K150751

Cordelle II Sound Processor by Cochlear Americas — Product Code LXB

K150751 is an FDA 510(k) premarket notification submitted by Cochlear Americas for the device "Cordelle II Sound Processor". The FDA issued a decision of Substantially Equivalent on July 22, 2015. The device falls under product code LXB (Hearing Aid, Bone Conduction), a Class II device regulated under 21 CFR 874.3302. Cochlear Americas has at least 10 other 510(k) clearances on record.