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

    THE BELMONT RAPID INFUSER

    K Number: K141654 · Decision Jul 18, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    159
    Registration Numbers
    159
    Same Product Code
    844
    Applicant Total
    2
    Review Days
    28

    Basic Information

    Device Name
    THE BELMONT RAPID INFUSER
    K Number
    K141654
    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
    June 20, 2014
    Decision Date
    July 18, 2014
    Product Code
    FRN
    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
    FRN Pump, Infusion

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    Other Clearances by BELMONT INSTRUMENT CORPORATION

    K Number Device Name
    K152208 The Belmont Hyperthermia Pump