Apparatus, Visual Reinforcement Audiometric
The Visual Reinforcement Audiometric Apparatus (product code LYN) is a diagnostic audiology device that uses visual reinforcement techniques, such as animated toys or lights, to condition and test hearing thresholds in infants and young children who cannot reliably respond to standard audiometric methods. Regulated under 21 CFR 874.1050 and classified as a Class 2 device, it requires a 510(k) premarket notification and falls under the Ear, Nose, and Throat specialty. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- LYN
- Device Class
- FDA class 2
- Regulation Number
- 874.1050
- Medical Specialty
- Ear, Nose, Throat
- Review Panel
- EN
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K950995 | SENSICARE SYNTHETIC, SURGICAL GLOVE LINER | Jun 28, 1995 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K897143 | VERA 103 | Apr 27, 1990 | Substantially Equivalent | Madsen North America, Inc. |
| K880259 | VISUAL REINFORCE. AUDIO CASSETTE UNIT: BASIC & ADV | Apr 03, 1989 | Substantially Equivalent | Colorado Hearing Systems, Inc. |