BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    OXYTOTE INFINITY SERIES VIPR SYSTEMS

    K Number: K142149 · Decision Apr 17, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    12
    Applicant Total
    1
    Review Days
    255

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    Basic Information

    Device Name
    OXYTOTE INFINITY SERIES VIPR SYSTEMS
    K Number
    K142149
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.2700
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Western/Scott Fetzer Co.
    Date Received
    August 5, 2014
    Decision Date
    April 17, 2015
    Product Code
    ECX
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    ECX Cylinder, Compressed Gas, And Valve

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