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

    Eko Analysis Software

    K Number: K192004 · Decision Jan 15, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    305
    Applicant Total
    6
    Review Days
    173

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    Basic Information

    Device Name
    Eko Analysis Software
    K Number
    K192004
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Eko Devices, Inc.
    Date Received
    July 26, 2019
    Decision Date
    January 15, 2020
    Product Code
    MWI
    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
    MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

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    Other Clearances by Eko Devices, Inc.

    K Number Device Name
    K230111 CORE 500 Digital Stethoscope
    K213794 Eko Murmur Analysis Software (EMAS)
    K200776 Eko CORE
    K170874 Eko Model E5 System (EME5), Eko DUO
    K151319 Eko Electronic Stethoscope System