DEN250014
- 510(k) number
- DEN250014
- Device name
- Tyto Insights for Eardrum Bulging Detection
- Applicant
- Tyto Care , Ltd. IL
- Product code
- SHL — Ear, Nose, And Throat Image Analyzer
- Decision date
- 2026-03-17
- Date received
- 2025-04-21
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Ear, Nose, Throat
Official FDA record: DEN250014
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.