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

    A.S.A.P.

    K Number: K841318 · Decision Jul 18, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    59
    Applicant Total
    58
    Review Days
    107

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    Basic Information

    Device Name
    A.S.A.P.
    K Number
    K841318
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Trimedyne, Inc.
    Date Received
    April 2, 1984
    Decision Date
    July 18, 1984
    Product Code
    LDR
    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
    LDR Controller, Infusion, Intravascular, Electronic

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