510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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LZIClass II

Device, Assistive Listening

21 CFR 874.3320 / Ear, Nose, Throat
FDA source (opens on fda.gov)

LZI is the FDA product code for Device, Assistive Listening, a class II device type, regulated under 21 CFR 874.3320. As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LZI
Device name
Device, Assistive Listening
Regulation
21 CFR 874.3320
Device class
Class II
Review panel
Ear, Nose, Throat
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
7
Ingested recalls
0

Clearances, product code LZI

By decision year
7 clearances under product code LZI with a decision year between 1991 and 2004, 1995 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code LZI by decision year
YearClearances
19911
19941
19952
19972
20041

Applicants with the most clearances

Product code LZI
Applicants holding the most 510(k) clearances under product code LZI
ApplicantClearances
Williams Sound, LLC2
Bellab1
Je Liss & Co., Inc.1
Krueger Laboratories1
National Hearing Aid Dist., Inc.1
Phonic Ear, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code