LYN — Apparatus, Visual Reinforcement Audiometric Class II
FDA product code LYN covers "Apparatus, Visual Reinforcement Audiometric", a Class II medical device regulated under 21 CFR 874.1050. Submissions are reviewed by the Ear, Nose, Throat panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LYN
- Device Class
- Class II
- Regulation Number
- 874.1050
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K950995 | bd becton dickinson vacutainer systems preanalytic | SENSICARE SYNTHETIC, SURGICAL GLOVE LINER | June 28, 1995 |
| K897143 | madsen north america | VERA 103 | April 27, 1990 |
| K880259 | colorado hearing systems | VISUAL REINFORCE. AUDIO CASSETTE UNIT: BASIC & ADV | April 3, 1989 |