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

    4004 CONSTANT FLOW REGULATOR

    K Number: K813466 · Decision Jan 7, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    111
    Registration Numbers
    112
    Same Product Code
    54
    Applicant Total
    2
    Review Days
    27

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    Basic Information

    Device Name
    4004 CONSTANT FLOW REGULATOR
    K Number
    K813466
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.2700
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Safety Laboratories West
    Date Received
    December 11, 1981
    Decision Date
    January 7, 1982
    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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    Other Clearances by Safety Laboratories West

    K Number Device Name
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