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510(k) Data Aggregation

    K Number
    K983002
    Device Name
    MYSTIQUE ULTRASONIC NEBULIZER
    Manufacturer
    AIRSEP CORP.
    Date Cleared
    1998-10-16

    (49 days)

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

    MYSTIQUE ULTRASONIC NEBULIZER

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

    The Airsep Mystique ultrasonic nebulizer is intended for use in the treatment of asthma, COPD and other respiratory ailments in which an aerosolized medication is required during therapy. It may be necessary to perform respiratory therapy at anytime and anywhere the patient needs it. The Mystique nebulizer is not intended for use with Pentamidine. It is intended for single patient use.

    Device Description

    Mystique ultrasonic nebulizer

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) clearance letter from the FDA for the Mystique Ultrasonic Nebulizer, confirming its substantial equivalence to a legally marketed predicate device.

    It primarily discusses:

    • The FDA's decision to clear the device for market.
    • Regulatory classifications and requirements.
    • Instructions for the manufacturer regarding marketing and compliance.
    • Indications for Use for the Mystique ultrasonic nebulizer.

    There is no mention of specific acceptance criteria, study methodologies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

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