Tyto Insights for Eardrum Bulging Detection— 510(k) DEN250014
UnknownTyto Care , Ltd.
FDA 510(k) clearance DEN250014 for Tyto Insights for Eardrum Bulging Detection, Unknown on 2026-03-17. Applicant: Tyto Care , Ltd.. Device class: 2.
Summary
Tyto Care's Tyto Insights for Eardrum Bulging Detection is filed under SHL, ear, nose, and throat image analyzers. The record doesn't describe the product beyond its name and that code name.
Class II, 21 CFR 874.4775. Ear, Nose, and Throat is both the classification panel and the review panel. The record lists the submission type as Direct.
Tyto Care filed from Netanya, Israel. Review took 330 calendar days (April 21, 2025 to March 17, 2026).
Clearance details
- Applicant
- Tyto Care , Ltd.
- Product code
- Product code SHL
- Device class
- Class 2
- Regulation
- 21 CFR 874.4775
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Direct
- Location
- Netanya, IL
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