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

    Eko Foundation Analysis Software with Transformers (EFAST)

    K Number: K251494 · Decision Aug 12, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    153
    Applicant Total
    3
    Review Days
    89

    Basic Information

    Device Name
    Eko Foundation Analysis Software with Transformers (EFAST)
    K Number
    K251494
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1875
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Eko Health, Inc.
    Date Received
    May 15, 2025
    Decision Date
    August 12, 2025
    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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