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

    MYOCARDIAL TEMPERATURE MONITORING PROBES, CJ-1000

    K Number: K905652 · Decision Feb 14, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    8
    Review Days
    58

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    Basic Information

    Device Name
    MYOCARDIAL TEMPERATURE MONITORING PROBES, CJ-1000
    K Number
    K905652
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Daily Medical Products, Inc.
    Date Received
    December 18, 1990
    Decision Date
    February 14, 1991
    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 Daily Medical Products, Inc.

    K Number Device Name
    K914005 FIBEROPTIC TYMPANIC THERMOMETER, MODEL 6000
    K905568 TOPICAL COOLING PAD, MODEL 7000
    K896972 CARDIAC COOLING JACKET, 12 CM, MODEL CJ-520
    K896975 CARDIAC COOLING JACKET, 30% REDUCED, MODEL CJ-220
    K896974 CARDIAC COOLING JACKET, 8 CM, MODEL CJ-120
    K896973 CARDIAC COOLING JACKET, 30% ENLARGED, MODEL CJ-320
    K896971 CARDIAC COOLING JACKET, 8 CM, MODEL CJ-420