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

    Global Hypoperfusion Index (GHI) Algorithm

    K Number: K231038 · Decision Jul 26, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    4
    Applicant Total
    136
    Review Days
    105

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    Basic Information

    Device Name
    Global Hypoperfusion Index (GHI) Algorithm
    K Number
    K231038
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2210
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Edwards Lifesciences, LLC
    Date Received
    April 12, 2023
    Decision Date
    July 26, 2023
    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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