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510(k) Data Aggregation

    K Number
    K251160

    Validate with FDA (Live)

    Date Cleared
    2026-01-08

    (268 days)

    Product Code
    Regulation Number
    880.2910
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The sterile temperature probe is used with Mindray BeneVision N17 patient monitor to monitor body or skin surface temperature. The device is for use by qualified healthcare personnel.

    The probe is offered in the following three configurations:

    • Body cavity temperature probe for monitoring of the core temperature in adult and pediatric patients by insertion into the esophageal; and for monitoring of the body temperature in adult and pediatric patients by insertion into the rectal or nasopharyngeal cavity.
    • Skin contact temperature probe for monitoring of skin temperature to an adult and pediatric patient’s skin surface.
    • Ear cavity temperature probe for monitoring of body temperature by insertion of the foam into pediatric or adult’s auditory canal.

    For pediatric population, the subpopulations are children and adolescents.

    Device Description

    The sterile temperature probe is a compatible sensor for use with Mindary BeneVision N17 patient monitor, as an accessory of the legally marketed patient monitor on the US market, the sterile temperature probe is indicated for continuous monitoring of body temperature in hospital settings. It mainly consists of plug, cable, and probe at patient side. When in use, the probe should be connected to the compatible device, and the temperature change of the patient's measured part is sensed through the built-in NTC thermistor at the probe end and the patient's body temperature is measured. The subject devices are used with Mindray BeneVision N17 patient monitor, which was cleared under K182075.

    The temperature probes are packed individually into a paper plastic pouch in sterile condition and are single use only.

    AI/ML Overview

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