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510(k) Data Aggregation

    K Number
    K191004
    Device Name
    Advocate Non-Contact Infrared Thermometer
    Manufacturer
    BroadMaster Biotech, Corp.
    Date Cleared
    2019-09-05

    (142 days)

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

    BroadMaster Biotech, Corp.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Advocate Non-Contact Infrared Thermometer is a non-sterile, reusable, handheld device. It can be used by consumers in homecare environment and doctors in clinic as reference. It is intended for measuring human body temperature of all ranges of people by detecting infrared heat from the forehead.
    Device Description
    The Advocate Non-Contact Infrared Thermometer, model EF001S, measures temperatures of people by detecting the infrared energy radiated directly from the forehead without physical contact. The device is composed of a Probe of metals with infrared sensor inside to detect the infrared energy, an LCD Display, a SCAN button to start measuring temperatures, a Power switch button to switch on or off the device, a Body/Ambient button to switch between two measuring modes, and an Enclosure of ABS. The device has the following features: one-second measuring time, measuring Body or Ambient temperature, 12-memory recalls, "F/"C unit switchable, over range message (Hi/Lo), low battery indication, auto display for the last reading when power is on, auto shut-off when the device is idle for 60 seconds and voice function.
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    K Number
    K180355
    Device Name
    Advocate Non-Contact Infrared Thermometer
    Manufacturer
    BroadMaster Biotech, Corp.
    Date Cleared
    2019-01-10

    (336 days)

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

    BroadMaster Biotech, Corp.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Advocate Non-Contact Infrared Thermometer is a non-sterile, reusable, handheld device. It can be used by consumers in homecare environment and doctors in clinic as reference. It is intended for measuring human body temperature of all ranges of people by detecting infrared heat from the forehead.
    Device Description
    The Advocate Non-Contact Infrared Thermometer model EF001A measures temperatures of people by detecting the infrared energy radiated directly from the forehead without physical contact. The device is composed of a Probe of metals with infrared sensor inside to detect the infrared energy, an LCD Display, a SCAN button to start measuring temperatures, a Power switch button to switch on or off the device, a Body/Ambient button to switch between two measuring modes, and an Enclosure of ABS. The device has the following features: one-second measuring time, measuring Body or Ambient temperature, 12-memory recalls, 9F/℃ unit switchable, over range message (Hi/Lo), low battery indication, auto display for the last reading when power is on, and auto shut-off when the device is idle for 60 seconds.
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