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

    COPAL DIGITAL THERMOMETER UF-10

    K Number: K843040 · Decision Jan 3, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    518
    Registration Numbers
    518
    Same Product Code
    795
    Applicant Total
    11
    Review Days
    154

    Basic Information

    Device Name
    COPAL DIGITAL THERMOMETER UF-10
    K Number
    K843040
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    TAKEDA MEDICAL, INC.
    Date Received
    August 2, 1984
    Decision Date
    January 3, 1985
    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 TAKEDA MEDICAL, INC.

    K Number Device Name
    K854797 TAKEDA MEDICAL DIGITAL SPHYGMOMANOMETER, UA-731
    K853158 DIGITAL SPHYGMOMANOMETER MODEL 7620
    K851223 COPAL DIGITAL SPHYGMOMANOMETER UA-560
    K852564 COPAL UA-512 DIGITAL BLOOD PRESSURE MONITOR
    K843390 COPAL DIGITAL SPHYGMOMANOMETER UA-535
    K844285 COPAL DIGITAL SPHYGMOMAMOMETER UA-550
    K842388 COPAL DIGITAL SPHYGMOMANOMETER UA-510
    K844284 COPAL DIGITAL SPHYGMOMANOMETER UA-540
    K850195 COPAL DIGITAL THERMOMETER UF-12
    K850196 COPAL DIGITAL THERMOMETER UF-22B
    Search all 11 clearances from TAKEDA MEDICAL, INC. →