FDA Product Code
FDA Product Code SHL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ear, Nose, Throat
- 21 CFR Citation
- 874.4775
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261725 | OtoCompanion (Version 1.0) | Ironsides Medical, Inc. | 2026-09-21 | Traditional | PDF ↗ |
| DEN250014 | Tyto Insights for Eardrum Bulging Detection | Tyto Care , Ltd. | 2026-03-17 | Direct | — |
Product code SHL · Class II · Ear, Nose, Throat. Data: openFDA.