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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
CSD Labs GmbH
Niklaiplatz 4
graz,  AT 8020
Applicant Contact andreas reinisch
Hogan Lovells US LLP
3 Embarcadero Center
san francisco,  CA  94501
Correspondent Contact yarmela pavlovic
Regulation Number870.1875
Classification Product Code
Subsequent Product Code
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