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510(k) Data Aggregation

    K Number
    K980407
    Device Name
    HOPE NEBULIZER
    Manufacturer
    B & B MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    1998-05-27

    (113 days)

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

    HOPE NEBULIZER

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

    This device is to be used under medical supervision in hospitals, nursing homes, extended care facilities and outpatient clinics. The HOPE nebulizer is a high output nebulizer to be used by patients who require aerosolized medications. It provides additional hydration to help loosen secretions for patients whose condition is such that superior sympathomines, parasympathetic amines, or other appropriate medications would be nebulized. It is intended for use with bronchodilators, corticosteroids, antibiotics, mucolytics, and diagnostic formulations.

    Device Description

    HOPE Nebulizer

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA for the "Hope Nebulizer II". It indicates that the device has been found substantially equivalent to a predicate device marketed before May 28, 1976. However, this document does not contain any information regarding acceptance criteria, device performance studies, or details about such studies. It is a regulatory approval letter, not a study report or technical specification document.

    Therefore, I cannot provide the requested information based solely on the text provided.

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