Tyto Insights for Eardrum Bulging Detection
FDA 510(k) clearance DEN250014 · decided 2026-03-17
Clearance details
- K-number
- DEN250014
- Device name
- Tyto Insights for Eardrum Bulging Detection
- Applicant
- Tyto Care , Ltd.
- Decision
- Unknown
- Date received
- 2025-04-21
- Decision date
- 2026-03-17
- Days to decision
- 330 days
- Clearance type
- Direct
- Product code
- SHL
- Device class
- 2
- Regulation number
- 874.4775
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Netanya, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.