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

    CYL-FIL OXYGEN SYSTEM

    K Number: K061785 · Decision Sep 7, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    111
    Registration Numbers
    112
    Same Product Code
    54
    Applicant Total
    1
    Review Days
    76

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    Basic Information

    Device Name
    CYL-FIL OXYGEN SYSTEM
    K Number
    K061785
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.2700
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Responsive Respiratory, Inc.
    Date Received
    June 23, 2006
    Decision Date
    September 7, 2006
    Product Code
    CAN
    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
    CAN Regulator, Pressure, Gas Cylinder

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