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    K Number
    K050137
    Device Name
    TEMPTOUCH DERMAL THERMOMETER
    Manufacturer
    XILAS MEDICAL, INC.
    Date Cleared
    2005-03-18

    (53 days)

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

    XILAS MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TempTouch® Dermal Thermometer is an infrared thermometer for the measurement of skin surface temperature of people of all ages.
    Device Description
    Not Found
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    K Number
    K030829
    Device Name
    VPT METER
    Manufacturer
    XILAS MEDICAL, INC.
    Date Cleared
    2003-12-05

    (266 days)

    Product Code
    LLN
    Regulation Number
    882.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    XILAS MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VPT Meter is an instrument designed to measure simply and accurately the threshold of appreciation of vibration in human subjects.
    Device Description
    The Xilas Medical VPT Meter is designed to identify patients with sensory neuropathy. These patients have lost sensation and the "gift of pain" from their extremities or elsewhere. The instrument provides a quantitative measurement of vibration perception threshold (VPT). The digital device allows the clinician to quantify the loss of sensation, initially to establish a baseline loss of sensation and subsequently monitor the progression of established pathology.
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