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

    UNIVERSAL CONTROLLER, MODEL 100

    K Number: K934543 · Decision Mar 29, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    59
    Applicant Total
    1
    Review Days
    194

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    Basic Information

    Device Name
    UNIVERSAL CONTROLLER, MODEL 100
    K Number
    K934543
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Metamed, Inc.
    Date Received
    September 16, 1993
    Decision Date
    March 29, 1994
    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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