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

    OXYCARE(TM) OXYGEN CONTROLLER/MONITOR

    K Number: K924679 · Decision Feb 21, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    46
    Applicant Total
    9
    Review Days
    888

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    Basic Information

    Device Name
    OXYCARE(TM) OXYGEN CONTROLLER/MONITOR
    K Number
    K924679
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2500
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Air-Shields Vickers, Inc.
    Date Received
    September 16, 1992
    Decision Date
    February 21, 1995
    Product Code
    KLK
    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
    KLK Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia

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