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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 K181612
Device Name Tyto Stethoscope (OTC)
Applicant
Tyto Care , Ltd.
12 Haomanut St.
Netanya,  IL 4250445
Applicant Contact Stella Raizelman Perry
Correspondent
Third Party Review Group, LLC
25 Independence Blvd.
Warren,  NJ  07059
Correspondent Contact DAVE YUNGVIRT
Regulation Number870.1875
Classification Product Code
DQD  
Date Received06/19/2018
Decision Date 12/17/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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