BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Eko Model E5 System (EME5), Eko DUO

    K Number: K170874 · Decision May 19, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    153
    Applicant Total
    6
    Review Days
    56

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    Basic Information

    Device Name
    Eko Model E5 System (EME5), Eko DUO
    K Number
    K170874
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1875
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Eko Devices, Inc.
    Date Received
    March 24, 2017
    Decision Date
    May 19, 2017
    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 Eko Devices, Inc.

    K Number Device Name
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