BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Cap, Cooling (Infants)

    PMA: P040025 · Supplement: S013 · Decision Aug 29, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Cap, Cooling (Infants)
    Trade Name
    OLYMPIC COOL CAP
    PMA Number
    P040025
    Supplement Number
    S013
    Device Class
    FDA Class 3
    Product Code
    MXM
    Generic Name
    Cap, cooling (infants)
    Medical Specialty
    Unknown
    Advisory Committee
    Neurology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 29, 2013
    Date Received
    May 28, 2013
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A SOFTWARE PATCH THAT ALLOWS THE WATCHDOG TIMER TO REBOOT THE DEVICE AND INITIATE A POWER FAILURE RECOVERY ALARM IN THE EVENT OF A SCREEN FREEZE CONDITION.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MXM Cap, Cooling (Infants)