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510(k) Data Aggregation

    K Number
    K101244
    Device Name
    SKIN SENSOR PROBE, GENERAL PURPOSE PROBE, TYMPANIC PROBE
    Manufacturer
    TRUER MEDICAL INC.
    Date Cleared
    2010-11-18

    (198 days)

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

    TRUER MEDICAL INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the temperature probes is to measure temperature by a resistor that is sensitive to temperature changes. The probe is connected to the patient monitor by using an interconnect cable. These probes have skin or core contact with a patient. Skin probe (SSP 400 and SSP 700): The Skin Sensor Probe is indicated for use in the routine monitoring of skin temperature. It is individually packaged. The skin temperature probe is designed for use with Data Scope, Protocol and DeBusk monitoring systems and other monitors capable with 400 Series temperature probes. The device is indicated for use by qualified medical personnel only. GP Probes (GP 9400, GP 9700 and GP 14400): The General Purpose Temperature Probe is intended for continuous temperature monitoring. The probe is inserted into the nasopharynx, mouth or the rectum. It is individually packaged. The temperature probe beneath the cuff at the distal tip is designed for use with Data Scope, Protocol and DeBusk monitoring systems and other monitors capable with 400 Series temperature probes. The device is indicated for use by qualified medical personnel only. Tympanic Probe (TP 400 and TP 700: The Tympanic Probe is intended for monitoring patient temperature through the outer auditory ear canal. It is individually packaged. The tympanic Probe is designed for use with Data Scope, Protocol and DeBusk monitoring systems and other monitors capable with 400 Series temperature probes. The device is indicated for use by qualified medical personnel only.
    Device Description
    The intended use of the temperature probes is to measure temperature by a resistor that is sensitive to temperature changes. The probe is connected to the patient monitor by using an interconnect cable. These probes have skin or core contact with a patient.
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    K Number
    K092716
    Device Name
    ESOPHAGEAL STETHOSCOPE
    Manufacturer
    TRUER MEDICAL INC.
    Date Cleared
    2009-09-17

    (14 days)

    Product Code
    BZT
    Regulation Number
    868.1920
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRUER MEDICAL INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the esophageal stethoscope is to listen to heart and breath sounds while a patient is under anesthesia. Additionally, patient temperature can be monitored using the stethoscopes with 400 or 700 series thermistors. The stathoscopes are provided "packaged clean" and are for "single use" only.
    Device Description
    Not Found
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