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510(k) Data Aggregation

    K Number
    K132140
    Device Name
    DUTECK(MICHEALTH)DIGITAL CLINICAL THERMOMETER
    Date Cleared
    2014-02-04

    (208 days)

    Product Code
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    DUTECK INDUSTRIAL CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Duteck (micHealth) Digital Clinical Thermometer, DT2306 series (product code FLL) is used to measure human body temperature with the following features: The device display body temperature in digital format at LCD The device make intended contact with patient in 2 ways (1) Surface contact: armpit. (2) Invasive contact: oral. The device is used and installed by patients, Nurses, doctors and people with the exception of handicapped people and children. The device is used in ENVIRONMENT of room temperature and normal environment condition.
    Device Description
    Duteck (micHealth) Digital Clinical Thermometer, DT2306 series is hand-held, reusable, battery operated device that can measure human body temperature via the human oral and armpit.
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    K Number
    K060642
    Device Name
    DUTECK BODY COMPOSITION ANALYZER
    Date Cleared
    2006-06-07

    (89 days)

    Product Code
    Regulation Number
    870.2770
    Why did this record match?
    Applicant Name (Manufacturer) :

    DUTECK INDUSTRIAL CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    DUTECK (MicHealth) Body Composition Analyzer, BSA series are stand-on, non-invasive, reusable analyzer, measure body weight and impedance and estimates body non-invasive, of body fat, body water and skeletal muscle mass by using BIA method (bioelectrical impedance analysis). They are intended to use by healthy people age 10 to 80, (offective lifestyles for body composition assessment in the home environment.
    Device Description
    DUTECK (MicHealth) Body Composition Analyzer, BSA series are stand-on, non-invasive, reusable analyzer, measure body weight and impedance and estimates body non-invasive, of body fat, body water and skeletal muscle mass by using BIA method (bioelectrical impedance analysis).
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    K Number
    K021601
    Device Name
    MICHEALTH ET 1100/ET 1200 INFARED EAR THERMOMETER
    Date Cleared
    2002-07-10

    (56 days)

    Product Code
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    DUTECK INDUSTRIAL CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used in the home setting.
    Device Description
    The device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal.
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    K Number
    K992327
    Device Name
    DUTECK DIGITAL CLINICAL THERMOMETER
    Date Cleared
    1999-08-18

    (37 days)

    Product Code
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    DUTECK INDUSTRIAL CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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