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510(k) Data Aggregation

    K Number
    K152508
    Device Name
    Ageless Health Medical Digital Thermometer
    Manufacturer
    DONGGUAN AGELESS HEALTH INDUSTRIAL CO., LTD
    Date Cleared
    2015-12-31

    (120 days)

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

    DONGGUAN AGELESS HEALTH INDUSTRIAL CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ageless Health Medical Digital Thermometers are intended for use in measuring human body temperature (Armpit or Oral).
    Device Description
    Ageless Health Medical Digital Thermometers comprises a thermistor for getting temperature signal, a reference resistor for comparing the resistance of the thermistor, a buzzer for sounding effect, an ASIC for processing the target temperature digitally, and a LCD for displaying the temperature result. The design principle of thermometer is based on thermosensor and ASIC technology. A thermistor is used as thermosensor. The ASIC gets the sensor's signal from human body, then processes the signal and calculates the result, after that displays the temperature result by a LCD.
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    K Number
    K151281
    Device Name
    AGE Automatic Wrist Blood Pressure Monitor
    Manufacturer
    DONGGUAN AGELESS HEALTH INDUSTRIAL CO., LTD
    Date Cleared
    2015-06-30

    (47 days)

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

    DONGGUAN AGELESS HEALTH INDUSTRIAL CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AGE Automatic Wrist Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 13.5cm~19.5cm.
    Device Description
    AGE Automatic Wrist Blood Pressure Monitor is a battery driven automatic non-invasive blood pressure meter. It can automatically conduct the inflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult at wrist within its claimed range and accuracy via the Oscillometry technique. The device also has low voltage indication, which will be triggered when the battery is low.
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