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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stethoscope, Electronic
510(k) Number K252089
Device Name Tyto Stethoscope (G3)
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 Number870.1875
Classification Product Code
DQD  
Date Received07/02/2025
Decision Date 03/12/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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