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

    STA-SET MODEL 250 I.V. FLOW REGULATOR

    K Number: K864229 · Decision Dec 16, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    59
    Applicant Total
    1
    Review Days
    49

    Basic Information

    Device Name
    STA-SET MODEL 250 I.V. FLOW REGULATOR
    K Number
    K864229
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    STA-SET CORP.
    Date Received
    October 28, 1986
    Decision Date
    December 16, 1986
    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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