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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 K181988
Device Name eMurmur ID
Applicant
Csd Labs GmbH
Niklaiplatz 4
Graz,  AT 8020
Applicant Contact Andreas Reinisch
Correspondent
Hogan Lovells US LLP
3 Embarcadero Center
San Francisco,  CA  94501
Correspondent Contact Yarmela Pavlovic
Regulation Number870.1875
Classification Product Code
DQD  
Subsequent Product Code
DQC  
Date Received07/25/2018
Decision Date 04/17/2019
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		 No
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