Skip to contentDe Novo DEN250014
- Device
- Tyto Insights for Eardrum Bulging Detection
- Contact
- stella raizelman perry
- De Novo number
- DEN250014
- Product code
- SHL
- Regulation
- 874.4775
- Classification name
- ear, nose, and throat image analyzer
- Decision
- granted (DENG)
- Decision date
- 2026-03-17
- Date received
- 2025-04-21
- Classification advisory
- Ear Nose & Throat
- Review advisory
- Ear Nose & Throat
- Type
- Direct
Current FDA Classification#
- Product code
- SHL
- Device name
- Ear, Nose, And Throat Image Analyzer
- Medical specialty
- Ear, Nose, Throat
- Device class
- 2
- Regulation
- 874.4775
- Implant
- N
- Life sustain/support
- N