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510(k) Data Aggregation

    K Number
    K023510
    Device Name
    TRUTEK SELECT MODEL TT-1001
    Manufacturer
    Date Cleared
    2003-02-04

    (106 days)

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

    TRUTEK, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The TruTek Select Model TT-1001 is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal. It is intended for use by the medical professional on the adult and pediatric patient.
    Device Description
    The TruTek Select Model TT-1001 is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal.
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