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

    EZ-ASSIST-FILL

    K Number: K121661 · Decision Dec 27, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    205

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    Basic Information

    Device Name
    EZ-ASSIST-FILL
    K Number
    K121661
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5050
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Assist Fill, LLC
    Date Received
    June 5, 2012
    Decision Date
    December 27, 2012
    Product Code
    PCM
    Advisory Committee
    Physical Medicine
    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
    PCM Portable Liquid Oxygen Unit Stand