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510(k) Data Aggregation

    K Number
    K161211
    Device Name
    Digital Thermometer
    Date Cleared
    2016-08-29

    (123 days)

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

    BIOCARE ASIA CORPORATION LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Digital Thermometer is intended to measure body temperature in axillary, oral or rectum and to be used by medical professionals in clinical and hospital environments or consumers in a home environment. It is intended for use on people of all ages.
    Device Description
    The Digital Thermometers, 1004/1005, enable easy and accurate measuring over the body temperature range. It must be used in conjunction with a disposable probe cover when measuring temperature. From the construction point of view, the digital thermometer comprises of a thermistor for temperature sensing, a reference resistor for comparison of temperature, a buzzer for sounding effect, an application specified IC for calculating, and an LCD for displaying the measured temperature reading which the thermistor contacts and senses.
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    K Number
    K141924
    Device Name
    HD BLOOD PRESSURE MONITOR
    Date Cleared
    2014-09-08

    (54 days)

    Product Code
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOCARE ASIA CORPORATION LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    HD 3161 Blood Pressure Monitor is intended to be used to measure the systolic and diastolic blood pressure and pulse rate by using a non-invasive technique in which an inflatable cuff is wrapped on the upper arm. This system should only be used for the testing on people over 18 years of age and over. This device is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated. The cuff circumference is limited to be 9.44 to 16.9 inches (24cm〜43cm).
    Device Description
    HD 3161 Blood Pressure Monitor measures both systolic and diastolic blood pressure and heart pulse rate via a standard oscillometric method. The oscillometric method senses the vibrating signal via the closed air pipe system and utilizes a microcomputer to automatically sense the characteristics of the pulse signal. Unlike with the traditional measuring method, based on the Korotkov sound, with the oscillometric method the use of a stethoscope is not required. Through simple calculations, this method provides accurate blood pressure readings: the systolic pressure is defined as the blood pressure when the cuff pressure oscillating amplitude begins to increase, while the diastolic blood pressure is defined as the pressure when the cuff pressure oscillating amplitude stops decreasing.
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    K Number
    K132457
    Device Name
    FORA DIAMOND NEXUS MINI INFRARED FOREHEAD THERMOMETER
    Date Cleared
    2014-02-21

    (199 days)

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

    BIOCARE ASIA CORPORATION LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    FORA Diamond Nexus Mini Thermometer is intended for the intermittent measurement and monitoring of human body temperature from forehead measurement at home.
    Device Description
    FORA Diamond Nexus Mini Infrared Forehead Thermometer is characterized by measuring human body temperature from the surface of human skin. It utilizes infrared technology to measure infrared energy emitted from the skin surface when making a temperature measurement.
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