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510(k) Data Aggregation

    K Number
    K150591
    Device Name
    Besmed Reusable Jet Nebulizer
    Manufacturer
    BESMED HEALTH BUSINESS CORP.
    Date Cleared
    2015-06-30

    (113 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Besmed Reusable Jet Nebulizer is a handheld, pneumatic nebulizer designed to aerosolize prescription drugs for inhalation by a patient. Its use is indicated whenever a healthcare professional administers or prescribes medical aerosol products to a patient using a small volume nebulizer.

    Device Description

    The Besmed Reusable Jet Nebulizer is a handheld, pneumatic nebulizer designed to aerosolize prescription drugs for inhalation by a patient.

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for the Besmed Reusable Jet Nebulizer. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter primarily states that the device has been found substantially equivalent to a legally marketed predicate device and outlines regulatory responsibilities.

    Therefore, I cannot provide the requested information based on the provided text. The document focuses on regulatory approval, not on the technical performance testing of the device against specific acceptance criteria.

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