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510(k) Data Aggregation

    K Number
    K031370
    Device Name
    SHINMED MODE SW-988 UNTRASONIC NEBULIZER
    Manufacturer
    SHINING WORLD HEALTH CARE CO., LTD.
    Date Cleared
    2004-09-01

    (490 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SHINMED MODE SW-988 UNTRASONIC NEBULIZER

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

    The Shinmed Ultrasonic Nebulizer SW-988 is intended to spray liquid medications in aerosol form into gases that are directly delivered to the patient.

    Device Description

    SHINMED model SW-988 Ultrasonic Nebulizer

    AI/ML Overview

    I am sorry, but the provided text is a Food and Drug Administration (FDA) 510(k) clearance letter for a medical device (SHINMED Model SW-988 Ultrasonic Nebulizer). This document primarily focuses on the regulatory approval process, stating that the device is substantially equivalent to legally marketed predicate devices.

    The letter does not contain the detailed technical information required to answer your questions about acceptance criteria, specific study designs, sample sizes, expert qualifications, or ground truth establishment. These details would typically be found in the 510(k) submission itself or in accompanying clinical/technical reports, which are not part of the provided text.

    Therefore, I cannot provide the requested information based solely on the given input.

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