Device, Assistive Listening

FDA product code LZI · Class II (moderate risk) · 21 CFR 874.3320 · Ear, Nose, Throat

7510(k) clearances
0PMA approvals
0recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K043090Easylistener 2 FM, Radium FM and Vocalight Infrared Sound Field SystemsLZI · Traditional Phonic Ear, Inc.12/23/2004SE
K970974Williams Sound, Personal FM System, Hearing HelperLZI · Traditional Williams Sound, LLC05/02/1997SE
K970340Air Conduction Assistive Listening Device.Personal AmplifierLZI · Traditional Bellab03/26/1997SE
K954748Pocketalker ProLZI · Traditional Williams Sound, LLC11/22/1995SE
K952057Listenaider IILZI · Traditional National Hearing Aid Dist., Inc.06/21/1995SE
K934805HearitLZI · Traditional Je Liss & Co., Inc.02/07/1994SE
K904755Acoustiq Listening DeviceLZI · Traditional Krueger Laboratories01/29/1991SE