BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇹 Austria

    eMurmur ID

    K Number: K181988 · Decision Apr 17, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    153
    Applicant Total
    2
    Review Days
    266

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    Basic Information

    Device Name
    eMurmur ID
    K Number
    K181988
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1875
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Csd Labs GmbH
    Date Received
    July 25, 2018
    Decision Date
    April 17, 2019
    Product Code
    DQD
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DQD Stethoscope, Electronic

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    Other Clearances by Csd Labs GmbH

    K Number Device Name
    K220766 eMurmur Heart AI