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

    OXY MONITOR 5-RANGE DUAL-THERMISTOR

    K Number: K832652 · Decision Dec 22, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    46
    Applicant Total
    38
    Review Days
    136

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    Basic Information

    Device Name
    OXY MONITOR 5-RANGE DUAL-THERMISTOR
    K Number
    K832652
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2500
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Litton Medical Electronics
    Date Received
    August 8, 1983
    Decision Date
    December 22, 1983
    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 Litton Medical Electronics

    K Number Device Name
    K840522 RECOMED BLOOD-FLOW METER H236-052-02
    K840899 SERVOMED ARRHYCOMP CENTRAL MONITOR SYS
    K840439 RECOMED CARDIAC OUTPUT METER 236067-
    K840523 SERVOMED PULSE AMPLIFIER MODULE-206-
    K840524 SERVOMED BASIC BEDSIDE UNIT SMV 110TP
    K840209 SERVOMED MEDIVISION SCOPE SMV-235
    K840832 SERVOMED OXCARDIORE SPIROGRAPH 324/111
    K840521 SERVOMED DIGITAL DISPLAY MODULE
    K832250 SERVOMED BASIC BEDSIDE UNIT SMA 102-
    K832998 2-CHANNEL RECORDER
    Search all 38 clearances from Litton Medical Electronics →