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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Abnormal Breath Sound Device
510(k) Number K243567
Device Name Tyto Insights for Rhonchi Detection
Applicant
Tyto Care , Ltd.
14 Beni Gaon St.
Netanya,  IL
Applicant Contact Stella Raizelman Perry
Correspondent
Tyto Care , Ltd.
14 Beni Gaon St.
Netanya,  IL
Correspondent Contact Stella Raizelman Perry
Regulation Number868.1900
Classification Product Code
PHZ  
Date Received11/18/2024
Decision Date 04/07/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Clinical Trials NCT06460246
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 Yes
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