FDA Product Code
FDA Product Code NIX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ear, Nose, Throat
- 21 CFR Citation
- 874.3950
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K040996 | RETROX TITANIUM TUBE SYSTEM FOR THE RETROX TRANSCUTANEOUS AIR CONDUCTION HEARING AID SYSTEM | Gyrus Ent LLC | 2004-08-20 | Traditional | PDF ↗ |
| DEN020003 | RETROX | Auric Hearing Systems, Inc. | 2002-08-20 | Post-NSE | — |
Product code NIX · Class II · Ear, Nose, Throat. Data: openFDA.