510(k) DEN250014
- Device
- Tyto Insights for Eardrum Bulging Detection
- Applicant
- Tyto Care , Ltd.
- 510(k) number
- DEN250014
- Product code
- SHL
- Decision
- Unknown (DENG)
- Decision date
- 2026-03-17
- Date received
- 2025-04-21
- Regulation
- 874.4775
- Classification name
- Ear, Nose, And Throat Image Analyzer
- Medical specialty
- Ear, Nose, Throat
- Review panel
- Ear, Nose, Throat
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Stella Raizelman Perry
- Address
- 14 Beni Gaon St. Netanya IL
FDA Registration Numbers#
- 3012678246
Source Documents#
510(k) summary PDF not indicated by FDA