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

    ACCUFUSER; ACCUFUSER PLUS

    K Number: K003915 · Decision Feb 15, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    86
    Applicant Total
    1
    Review Days
    58

    Basic Information

    Device Name
    ACCUFUSER; ACCUFUSER PLUS
    K Number
    K003915
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    HELPTECHNOLOGIES
    Date Received
    December 19, 2000
    Decision Date
    February 15, 2001
    Product Code
    MEB
    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
    MEB Pump, Infusion, Elastomeric

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