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

    APPRAISE-HRI

    K Number: K233249 · Decision Apr 5, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    2
    Review Days
    190

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    Basic Information

    Device Name
    APPRAISE-HRI
    K Number
    K233249
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2220
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    The Surgeon General, Department of the Army (TSG-DA)
    Date Received
    September 28, 2023
    Decision Date
    April 5, 2024
    Product Code
    SAR
    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
    SAR Adjunctive Hemodynamic Indicator With Decision Point For Military Use

    Other Clearances by The Surgeon General, Department of the Army (TSG-DA)

    K Number Device Name
    K253116 3D MAC Titanium Cranial Plate (TCP) System