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510(k) Data Aggregation

    K Number
    K210937

    Validate with FDA (Live)

    Device Name
    Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241
    Manufacturer
    Alicn Medical Shenzhen, Inc.
    Date Cleared
    2022-05-12

    (409 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 Electronic Thermometers (AET-F101, AET-F221, AET-F241) are intended to measure human body temperature orally or under the arm. The devices are reusable for clinical or home use on people of all ages.

    Device Description

    Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241

    AI/ML Overview

    I am sorry, but the provided text is an FDA 510(k) clearance letter for an Electronic Thermometer. It does not contain information about the acceptance criteria, device performance, or any studies using AI or human readers. The document is a regulatory approval and does not detail the technical performance evaluation in the way requested in your prompt.

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