LYN · Apparatus, Visual Reinforcement Audiometric
Ear, Nose, Throat · 21 CFR 874.1050 · Class 2
Overview
| Product Code | LYN |
|---|---|
| Device Name | Apparatus, Visual Reinforcement Audiometric |
| Regulation | 21 CFR 874.1050 |
| Device Class | Class 2 |
| Review Panel | Ear, Nose, Throat |
Identification
An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.
Classification Rationale
Class II. Except for the otoacoustic emission device, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, if it is in compliance with American National Standard Institute S3.6-1996, “Specification for Audiometers,” and subject to the limitations in § 874.9.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K950995 | SENSICARE SYNTHETIC, SURGICAL GLOVE LINER | Bd Becton Dickinson Vacutainer Systems Preanalytic | Jun 28, 1995 | SESE |
| K897143 | VERA 103 | Madsen North America, Inc. | Apr 27, 1990 | SESE |
| K880259 | VISUAL REINFORCE. AUDIO CASSETTE UNIT: BASIC & ADV | Colorado Hearing Systems, Inc. | Apr 3, 1989 | SESE |
Top Applicants
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
- Colorado Hearing Systems, Inc. — 1 clearance
- Madsen North America, Inc. — 1 clearance
