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510(k) Data Aggregation

    K Number
    K111463
    Device Name
    VALEO VT-601 SERIES IR THERMOMETER
    Manufacturer
    VALEO CORP.
    Date Cleared
    2012-02-17

    (267 days)

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

    VALEO CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Valeo VT-601 Series IR Thermometer, (Model no.: VT-601D, VT-601E, VT-601F) is infrared thermometer intended for the intermittent measurement of human body temperature in people of all ages.
    Device Description
    The Valeo VT-601 Series IR Thermometer, (Model no.: VT-601D, VT-601E . VT-601F) is hand-held, non-sterile, reusable, battery operated device that can measure human body temperature. The Valeo VT-601D IR Forehead/ Ear Thermometer can measure human body temperature in 2 ways: (1) The temporal artery over forehead. (2) Tympanic temperature via the human ear. The Valeo VT-601E IR Ear Thermometer measures human body temperature natural thermal infrared radiation emitted from the ear tympanic. The Valeo VT-601F IR Forehead Thermometer measure human body temperature by the temporal artery over forehead. Operation is based on the measuring of the natural thermal infrared radiation emitted from the surface of the skin over the temporal artery or from the ear tympanic.
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    K Number
    K002562
    Device Name
    PACIFIER THERMOMETER MODELS VT-901F, VT901C
    Manufacturer
    VALEO CORP.
    Date Cleared
    2000-10-13

    (57 days)

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

    VALEO CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K982140
    Device Name
    CLINICAL ELECTRONIC THERMOMETER
    Manufacturer
    VALEO CORP.
    Date Cleared
    1998-12-08

    (174 days)

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

    VALEO CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device measures the body temperature of a patient by means of a sensor (transducer) coupled with an electronic signal amplification, conditioning and digital LCD (display) unit. The device is reusable and intended for oral, axillary or rectal temperature measurements.
    Device Description
    Clinical Electronic Thermometer
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