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510(k) Data Aggregation

    K Number
    K981944
    Device Name
    BREATHERITE
    Manufacturer
    VENTLAB CORP.
    Date Cleared
    1998-08-24

    (82 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

    VENTLAB Corporation's BreatheRite MDI Spacer is designed to work in conjunction with a metered dose inhaler (MDI) to provide a dispersion chamber that will aid the sufferer in inhaling a suitable asthmatic medication properly.

    Device Description

    The BreatheRite MDI Spacer consists of a chamber that secures the metered dose inhalers mouthpiece with an elastomeric flange adapter at one end, a chamber connected to a one-way valve adapter, which opens on inhalation, and an exhalation adapter that allows the air to exhaust to the atmosphere both of which are housed within the mouthpiece.

    AI/ML Overview

    This document is a 510(k) clearance letter and an "Indications for Use" statement for the BreatheRite MDI Spacer. It does not contain information about acceptance criteria, device performance studies, or the methodologies used to establish ground truth.

    Therefore, I cannot provide the requested information based solely on the provided text. The document confirms that the device was deemed substantially equivalent to a legally marketed predicate device, but it does not detail the specific studies or data that led to this determination.

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