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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 K252284
Device Name eMurmur Heart AI
Applicant
Csd Labs
Krenngasse 12
Graz,  AT 8010
Applicant Contact Andreas Reinisch
Correspondent
RQM+
2790 Mosside Blvd.
#800
Monroeville,  PA  14156
Correspondent Contact Allison C. Komiyama
Regulation Number870.1875
Classification Product Code
DQD  
Subsequent Product Code
DQC  
Date Received07/22/2025
Decision Date 12/19/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 Yes
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