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

    MODEL 4070 TEMPERATURE MONITOR

    K Number: K895875 · Decision Dec 21, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    3
    Review Days
    78

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    Basic Information

    Device Name
    MODEL 4070 TEMPERATURE MONITOR
    K Number
    K895875
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Mallinckrodt Anesthesia Products
    Date Received
    October 4, 1989
    Decision Date
    December 21, 1989
    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 Mallinckrodt Anesthesia Products

    K Number Device Name
    K912240 CPAP SYSTEM AND BRONCHO-CATH W/CPAP SYSTEM
    K890484 HI-LO TEMP GENERAL PURPOSE TEMPERATURE PROBE