Tyto Insights for Eardrum Bulging Detection— 510(k) DEN250014

Unknown

Tyto Care , Ltd.

FDA 510(k) clearance DEN250014 for Tyto Insights for Eardrum Bulging Detection, Unknown on 2026-03-17. Applicant: Tyto Care , Ltd..

Clearance details

Applicant: Tyto Care , Ltd.
Product code: Code SHL
Advisory panel: Ear, Nose, Throat
Date received: 2025-04-21
Decision date: 2026-03-17
Decision: Unknown
Clearance type: Direct
Location: Netanya, IL

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