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

    TCM202 TCPO2 & TCM204 TCPO2/PO2 REC. SY.

    K Number: K802846 · Decision Dec 17, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    46
    Applicant Total
    7
    Review Days
    35

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    Basic Information

    Device Name
    TCM202 TCPO2 & TCM204 TCPO2/PO2 REC. SY.
    K Number
    K802846
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2500
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    The London Co.
    Date Received
    November 12, 1980
    Decision Date
    December 17, 1980
    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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