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

Apparatus, Visual Reinforcement Audiometric

21 CFR 874.1050 / Ear, Nose, Throat
FDA source (opens on fda.gov)

LYN is the FDA product code for Apparatus, Visual Reinforcement Audiometric, a class II device type, regulated under 21 CFR 874.1050. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LYN
Device name
Apparatus, Visual Reinforcement Audiometric
Regulation
21 CFR 874.1050
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
3
Ingested recalls
0

Clearances, product code LYN

By decision year
3 clearances under product code LYN with a decision year between 1989 and 1995, 1989 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code LYN by decision year
YearClearances
19891
19901
19951

Applicants with the most clearances

Product code LYN
Applicants holding the most 510(k) clearances under product code LYN
ApplicantClearances
BD Becton Dickinson Vacutainer Systems Preanalytic1
Colorado Hearing Systems, Inc.1
Madsen North America, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code