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510(k) Data Aggregation

    K Number
    K051699
    Device Name
    SEJOY, MODEL MT-403
    Manufacturer
    SEJOY ELECTRONICS & INSTRUMENTS CO., LTD.
    Date Cleared
    2006-02-06

    (227 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SEJOY, MODEL MT-403

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The device model MT-101 is intended to measure the human body temperature in regular mode orally, rectally or under the arm(axillary). The device is reusable for clinical or home use on people of all ages.

    Device Description

    Digital Thermometer Model MT-101

    AI/ML Overview

    This request cannot be fulfilled by the provided document. The document is an FDA 510(k) clearance letter for a digital thermometer. It confirms that the device is substantially equivalent to a predicate device and can be marketed, but it does not contain any details about acceptance criteria, specific studies, performance data, sample sizes, expert qualifications, or ground truth methodologies.

    The document primarily focuses on regulatory approval based on substantial equivalence, not on a detailed report of clinical study results or technical performance evaluations against specific criteria.

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