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510(k) Data Aggregation

    K Number
    K973176
    Device Name
    SEIZURE EMERGENCY EQUIPMENT KIT; SEIZURE KIT
    Manufacturer
    LOTUS TECHNOLOGIES
    Date Cleared
    1997-11-21

    (88 days)

    Product Code
    KGA
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Product Code :

    KGA

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

    During a seizure emergency, this device is indicated for use by a caretaker to render first aid to a person who is having a seizure.

    Device Description

    Seizure Emergency Equipment Kit

    AI/ML Overview

    The provided text is a letter from the FDA regarding a 510(k) premarket notification for a "Seizure Emergency Equipment Kit." This document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

    The letter is a regulatory approval for marketing the device based on its substantial equivalence to a predicate device already on the market. It confirms that the device can be marketed subject to general controls but does not include details of performance testing.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

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