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

    eCARTv5 Clinical Deterioration Suite (“eCART”)

    K Number: K233253 · Decision Jun 21, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    4
    Applicant Total
    1
    Review Days
    267

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    Basic Information

    Device Name
    eCARTv5 Clinical Deterioration Suite (“eCART”)
    K Number
    K233253
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2210
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Agilemd, Inc.
    Date Received
    September 28, 2023
    Decision Date
    June 21, 2024
    Product Code
    QNL
    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
    QNL Medium-Term Adjunctive Predictive Cardiovascular Indicator

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