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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
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