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

    The Belmont Hyperthermia Pump

    K Number: K152208 · Decision Sep 2, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    71
    Applicant Total
    2
    Review Days
    26

    Basic Information

    Device Name
    The Belmont Hyperthermia Pump
    K Number
    K152208
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    BELMONT INSTRUMENT CORPORATION
    Date Received
    August 7, 2015
    Decision Date
    September 2, 2015
    Product Code
    LGZ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LGZ Warmer, Thermal, Infusion Fluid

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    Other Clearances by BELMONT INSTRUMENT CORPORATION

    K Number Device Name
    K141654 THE BELMONT RAPID INFUSER