510(k) K173409

Wireless Audio System by Neocoil, LLC — Product Code LNH

K173409 is an FDA 510(k) premarket notification submitted by Neocoil, LLC for the device "Wireless Audio System". The FDA issued a decision of Substantially Equivalent on February 16, 2018. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Neocoil, LLC has at least 10 other 510(k) clearances on record.