BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    PO-510 TCPO2 MONITOR

    K Number: K852959 · Decision Nov 29, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    46
    Applicant Total
    2
    Review Days
    140

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    Basic Information

    Device Name
    PO-510 TCPO2 MONITOR
    K Number
    K852959
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2500
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Sumitomo Electric Industries, Inc.
    Date Received
    July 12, 1985
    Decision Date
    November 29, 1985
    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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    Other Clearances by Sumitomo Electric Industries, Inc.

    K Number Device Name
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