510(k) K043090

EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMS by Phonic Ear, Inc. — Product Code LZI

K043090 is an FDA 510(k) premarket notification submitted by Phonic Ear, Inc. for the device "EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMS". The FDA issued a decision of Substantially Equivalent on December 23, 2004. The device falls under product code LZI (Device, Assistive Listening), a Class II device regulated under 21 CFR 874.3320. Phonic Ear, Inc. has at least 10 other 510(k) clearances on record.