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510(k) Data Aggregation

    K Number
    K031130
    Device Name
    YA MEI FIRST AID KIT
    Manufacturer
    YA MEI TECHNOLOGY CO., LTD.
    Date Cleared
    2003-06-27

    (79 days)

    Product Code
    KGO,LRR
    Regulation Number
    878.4460
    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 Ya Mei First Aid Kit is intended to provide basic first aid treatment for various emergency situations, while seeking further professional medical assistance, when necessary.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding a "Ya Mei First Aid Kit." This document does not contain any information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.

    The document primarily focuses on:

    • Confirming that the device is substantially equivalent to legally marketed predicate devices.
    • Outlining the regulatory requirements the manufacturer must comply with.
    • Stating the intended use of the device: "The Ya Mei First Aid Kit is intended to provide basic first aid treatment for various emergency situations, while seeking further professional medical assistance, when necessary."

    Therefore, I cannot provide the requested table and study details based on the given information. The prompt asks for information that is simply not present in the provided FDA letter.

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