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

    VISITEC NEEDLE RANGE (GENERAL HOSPITAL)

    K Number: K811966 · Decision Jul 23, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    440
    Registration Numbers
    440
    Same Product Code
    687
    Applicant Total
    49
    Review Days
    13

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    Basic Information

    Device Name
    VISITEC NEEDLE RANGE (GENERAL HOSPITAL)
    K Number
    K811966
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5570
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Visitec Co.
    Date Received
    July 10, 1981
    Decision Date
    July 23, 1981
    Product Code
    FMI
    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
    FMI Needle, Hypodermic, Single Lumen

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