LZI
7 FDA 510(k) clearances · Product code
50 daysmedian time to decision
123 days90th percentile
7clearances measured
FDA profile
- Official device name
- Device, Assistive Listening
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.3320
- Medical specialty
- Ear, Nose, Throat
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMS (K043090) | Phonic Ear, Inc. | 2004-12-23 |
| WILLIAMS SOUND, PERSONAL FM SYSTEM, HEARING HELPER (K970974) | Williams Sound, LLC | 1997-05-02 |
| AIR CONDUCTION ASSISTIVE LISTENING DEVICE.PERSONAL AMPLIFIER (K970340) | Bellab | 1997-03-26 |
| POCKETALKER PRO (K954748) | Williams Sound, LLC | 1995-11-22 |
| LISTENAIDER II (K952057) | National Hearing Aid Dist., Inc. | 1995-06-21 |
| HEARIT (K934805) | Je Liss & Co., Inc. | 1994-02-07 |
| ACOUSTIQ LISTENING DEVICE (K904755) | Krueger Laboratories | 1991-01-29 |
Track LZI automatically
Every clearance here is in the API, with alerts when new ones post.