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510(k) Data Aggregation

    K Number
    K100563
    Device Name
    GEON RAPID DIGITAL THERMOMETER MODEL: MT-B117, MT-B127, MT-B130, MT-B132FA
    Manufacturer
    GEON CORPORATION
    Date Cleared
    2010-06-02

    (93 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The device is an digital thermometers intended for the intermittent measurement of human body temperature either in oral, rectal and axillaries (underarm) , by consumers in the home for people of all ages.

    Device Description

    Geon Rapid Digital Thermometer, Model no.: MT-B117 ,MT-B127 ,MT-B130 ,MT-B132FA

    AI/ML Overview

    This document is a 510(k) clearance letter for the Geon Rapid Digital Thermometer. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document only confirms that the device is substantially equivalent to legally marketed predicate devices.

    Therefore, I cannot answer your request based on the provided text.

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