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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 K212906
Device Name HeartBuds Electronic Stethoscope
Applicant
Heartbuds LLC
711 London Road
Winter Park,  FL  32792
Applicant Contact Seth Ellis
Correspondent
leanRAQA
131 E Loch Lomond Pl
Oro Valley,  AZ  85737
Correspondent Contact Michelle Lott
Regulation Number870.1875
Classification Product Code
DQD  
Date Received09/13/2021
Decision Date 03/14/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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