LZI · Class II · 21 CFR 874.3320

FDA Product Code LZI: Device, Assistive Listening

Leading manufacturers include Phonic Ear, Inc., Bellab and Williams Sound, LLC.

7
Total
7
Cleared
66d
Avg days
1991
Since

FDA 510(k) Cleared Device, Assistive Listening Devices (Product Code LZI)

7 devices
1–7 of 7
Cleared Dec 23, 2004
EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMS
K043090
Phonic Ear, Inc.
Ear, Nose, Throat · 45d
Cleared May 02, 1997
WILLIAMS SOUND, PERSONAL FM SYSTEM, HEARING HELPER
K970974
Williams Sound, LLC
Ear, Nose, Throat · 46d
Cleared Mar 26, 1997
AIR CONDUCTION ASSISTIVE LISTENING DEVICE.PERSONAL AMPLIFIER
K970340
Bellab
Ear, Nose, Throat · 56d

About Product Code LZI - Regulatory Context