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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 K160401
Device Name Tyto Stethoscope
Tyto Care Ltd.
Haomanut 12
Netanya,  IL 4205445
Applicant Contact Yoni Iger
BioMedical Strategy
155 Bialik St.
Ramat Gan,  IL 5252346
Correspondent Contact Orna Oz
Regulation Number870.1875
Classification Product Code
Date Received02/12/2016
Decision Date 10/19/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No