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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name ear, nose, and throat image analyzer
De Novo Number DEN250014
Device Name Tyto Insights for Eardrum Bulging Detection
Requester
tyto care , ltd.
14 beni gaon st.
netanya,  IL
Contact stella raizelman perry
Regulation Number874.4775
Classification Product Code
SHL  
Date Received04/21/2025
Decision Date 03/17/2026
Decision granted (DENG)
Classification Advisory Committee Ear Nose & Throat
Review Advisory Committee Ear Nose & Throat
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 Yes
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