Panels › Ear, Nose, Throat › Product code LZI · Class 2
Device, Assistive Listening
Regulation 874.3320
0510(k)s in 12 months (7 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in LZI
| Company | 510(k)s | Recalls |
|---|---|---|
| Williams Sound, LLC | 2 | 0 |
| Bellab | 1 | 0 |
| Je Liss & Co., Inc. | 1 | 0 |
| Krueger Laboratories | 1 | 0 |
| National Hearing Aid Dist., Inc. | 1 | 0 |
| Phonic Ear, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 23, 2004 | K043090 | EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMS Phonic Ear, Inc. | LZI |
| May 2, 1997 | K970974 | WILLIAMS SOUND, PERSONAL FM SYSTEM, HEARING HELPER Williams Sound, LLC | LZI |
| Mar 26, 1997 | K970340 | AIR CONDUCTION ASSISTIVE LISTENING DEVICE.PERSONAL AMPLIFIER Bellab, SE | LZI |
| Nov 22, 1995 | K954748 | POCKETALKER PRO Williams Sound, LLC | LZI |
| Jun 21, 1995 | K952057 | LISTENAIDER II National Hearing Aid Dist., Inc. | LZI |
| Feb 7, 1994 | K934805 | HEARIT Je Liss & Co., Inc. | LZI |
| Jan 29, 1991 | K904755 | ACOUSTIQ LISTENING DEVICE Krueger Laboratories | LZI |
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