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

    SMART LABEL, PROPOFOL

    K Number: K142333 · Decision Dec 18, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37
    Same Product Code
    47
    Applicant Total
    1
    Review Days
    119

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    Basic Information

    Device Name
    SMART LABEL, PROPOFOL
    K Number
    K142333
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    American I.V. Products, Inc. Dba Aiv, Inc.
    Date Received
    August 21, 2014
    Decision Date
    December 18, 2014
    Product Code
    MRZ
    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
    MRZ Accessories, Pump, Infusion

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