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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 K232237
Device Name Tyto Insights for Wheeze Detection
Applicant
Tyto Care Ltd.
14 Beni Gaon Street
Natanya,  IL 4250803
Applicant Contact Stella Raizelman Perry
Correspondent
Tyto Care Ltd.
14 Beni Gaon Street
Natanya,  IL 4250803
Correspondent Contact Stella Raizelman Perry
Regulation Number868.1900
Classification Product Code
PHZ  
Date Received07/28/2023
Decision Date 12/13/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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