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

    LME TEMP. MONITOR

    K Number: K832042 · Decision Aug 12, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    38
    Review Days
    49

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    Basic Information

    Device Name
    LME TEMP. MONITOR
    K Number
    K832042
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Litton Medical Electronics
    Date Received
    June 24, 1983
    Decision Date
    August 12, 1983
    Product Code
    FLL
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FLL Continuous Measurement Thermometer

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    Other Clearances by Litton Medical Electronics

    K Number Device Name
    K840522 RECOMED BLOOD-FLOW METER H236-052-02
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    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 →