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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 K220766
Device Name eMurmur Heart AI
Applicant
CSD Labs GmbH
Nikolaiplatz 4
Graz,  AT 8020
Applicant Contact Andreas Reinisch
Correspondent
RQM+
2251 San Diego Ave, Suite B-257
San Diego,  CA  92110
Correspondent Contact Allison Komiyama
Regulation Number870.1875
Classification Product Code
DQD  
Subsequent Product Code
DQC  
Date Received03/16/2022
Decision Date 05/31/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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