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510(k) Data Aggregation

    K Number
    K150160
    Device Name
    Temple Touch Pro (TTP) Non-invasive temperature monitoring system
    Manufacturer
    Date Cleared
    2015-10-20

    (270 days)

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

    MEDISIM LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The TTP™ is a non-sterile temperature monitoring system intended to measure and monitor core body temperature of patients of all ages, by applying a sensor unit on the forehead.
    Device Description
    The TTP™ system monitors the body core temperature through continuous measurements of the patient. The system is non-sterile and comprised of a disposable Sensor Unit, attached to the patient temple, and connected to a Monitor Connecting Unit which is connected to a power supply and to any YSI-400 input vital signs monitor, through which, the patient temperature is presented. The MCU is able to present the patient temperature as a standalone unit.
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    K Number
    K131155
    Device Name
    UGFT3; FHT7
    Manufacturer
    Date Cleared
    2013-08-28

    (126 days)

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

    MEDISIM LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The UGFT3 is a non-sterile, reusable clinical thermometer intended for the determination of human's body temperature using the temple (forehead); and/or underarm (axilla); and/or behind the ear as measurement sites.
    Device Description
    The UGFT3 is a non-sterile, reusable clinical thermometer intended for the determination of human's body temperature using the forehead and/or underarm and/or behind the ear as measurement sites. The UGFT3 is utilizing the Rapid Accurate Temperature Establishment (R.A.T.E.TM) technology, a technology based on the heat conduction principle, for determination of body temperature. Utilizing the R.A.T.E.TM technology, the device rapidly samples the heat flowing from the blood vessels to the skin surface. Then, based on the heat flow, the device calculates the blood vessel temperature, and then corrects this value to the body core temperature. User operation of the UGFT3 is identical to the operation of the Dual Mode Up Grade Forehead/Underarm Thermometer, cleared under K051422. The device allows user control by use of buttons located on the front panel of the device and the measured body temperature is displayed on an LCD screen, in Co or Fo units. The UGFT3 has an identical hardware as the UGFT2, as it uses the same thermistor sensor and electronic processing unit, however, the UGFT3 has a modified proprietary software algorithms. Device is made of ABS plastic and silicone rubber.
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    K Number
    K090386
    Device Name
    NON-INVASIVE INFRARED (NIR)
    Manufacturer
    Date Cleared
    2010-05-28

    (465 days)

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

    MEDISIM LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The NIR is non-sterile non-invasive infrared thermometer intended for the intermittent calculation of human body temperature of people of all ages for home and professional use.
    Device Description
    The device is built of one or more infrared thermopile sensors that is/are designed to measure a temperature above the artery on the skin. Each of the sensor/s is mounted on a reflector which is used to reduce the sensor field of view. In order to minimize distance effects on the readouts the device is equipped with a distance measurement sensor. Each of the thermopile/s has its own thermistor which is used for calculating the self temperature of each sensor. In addition there is another external thermistor which is used for measuring the ambient temperature and to asses the thermal condition of the thermal equilibrium of the device and to correct the result according to its value and the difference between the external sensor and the internal termistors readout.
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    K Number
    K051422
    Device Name
    DUAL MODE UP-GRADE FOREHEAD/UNDERARM THERMOMETER DEVICE
    Manufacturer
    Date Cleared
    2005-09-01

    (92 days)

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

    MEDISIM LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Dual Mode Up-Grade Forehead/ Underarm Thermometer device is intended for determination of body temperature. The Dual Mode Up-Grade Forehead/ Underarm Thermometer device is a non-sterile, reusable clinical thermometer intended for the determination of human's body temperature using the forehead and axilla as measurement sites.
    Device Description
    The Dual Mode Up-Grade Forehead/ Underarm Thermometer is a clinical electronic thermometer used for determination of body temperature. The over-the-counter Dual Mode Up-Grade Forehead/ Underarm Thermometer is designed to calculate the maximum temperature of a probe in contact with the body site, without waiting for thermal equilibrium to occur, by heat transfer data and mathematical algorithm. The temperature reading range is from 35.0°C to 42.0°C (95.5°F to 107.6°F) and the time of measurement is 6-10 seconds.
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    K Number
    K032362
    Device Name
    UP-GRADE FOREHEAD THERMOMETER
    Manufacturer
    Date Cleared
    2003-12-04

    (126 days)

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

    MEDISIM LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The UP-GRADE FOREHEAD THERMOMETER is a non-sterile, reusable clinical thermometer intended for the determination of human's body temperature using the forehead as measurement site.
    Device Description
    The over-the-counter Up-Grade Forehead Thermometer is a compact predictive clinical thermometer designed to measure human body temperature by detecting heat flow from the temporal artery, by using the heat conduction principle and prediction. The over-the-counter Up-Grade Forehead Thermometer is designed to calculate the maximum temperature of a probe in contact with the body site. without waiting for thermal equilibrium to occur, by heat transfer data and mathematical algorithm. The temperature reading range is from 35.0ºC to 42.0°C (95.5°F to 107.6°F) and the time of measurement is 6-10 seconds.
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    K Number
    K012217
    Device Name
    M5T INSTANT FEVER THERMOMETER
    Manufacturer
    Date Cleared
    2001-08-01

    (16 days)

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

    MEDISIM LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The M5T is non-sterile, reusable clinical thermometer intended for the determination of oral, rectal and axillary body temperature determination in humans.
    Device Description
    The M5T is a compact predictive clinical thermometer designed to measure human body temperature by detecting heat from three different body sites: axilla, rectum and mouth, by using the heat conduction principle and prediction. The M5T is designed to calculate the maximum temperature of a probe in contact with the body site. The temperature reading range is from 35.0℃ to 42.0℃ (95.5°F to 107.6°F) and the time of measurement varies between 8 to 10 seconds. The LCD, push button, battery, microprocessor and the PCB are located in one housing, which includes upper cover, lower cover and the battery cover. The entire device is compact, lightweight, small in size, easy to use and portable,
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    K Number
    K983887
    Device Name
    UP-GRADE AND UP-GRADE PRO
    Manufacturer
    Date Cleared
    1999-02-12

    (102 days)

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

    MEDISIM LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Up-Grade is an over-the-counter, non-sterile, reusable clinical thermometer intended for the determination of oral, rectal and axillary body temperature determination in humans.
    Device Description
    The Up-Grade is a compact predictive clinical thermometer designed to measure human body temperature by detecting heat from three different body sites: axilla, rectum and mouth, by using the heat conduction principle and prediction. The device is designed to calculate the maximum temperature of probe tip in contact with the body site, without waiting for thermal equilibrium to occur, by heat transfer data and mathematical algorithm. The temperature reading range is from 35.5℃ to 42.0℃ (95.5℃ to 107.6℃F) and the time of measurement varies between 4 to 6 seconds.
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