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510(k) Data Aggregation

    K Number
    K123030
    Device Name
    COMPRESSOR NEBULIZER MODEL MCN-S600XX
    Manufacturer
    DONGGUAN AIDISY MACHINERY & ELECTRONIC EQUIPMENT C
    Date Cleared
    2013-12-19

    (447 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

    Stronghealth Compressor Nebulizer MCN-S600XX is used to administer various aerosol treatments of all Subgream Compressor Nebulizer MCN-30007X is 350 a idinister or prescribes medical aerosol products to a patient using a Small Volume Nebulizer.

    The intended environment for use of the product is in the patient's home on the order of a physician.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA regarding the "Stronghealth Compressor Nebulizer MCN-S600XX." It primarily addresses the device's substantial equivalence to a predicate device and its regulatory classification. It does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.

    Therefore, I cannot provide the requested information, as it is not present in the provided text. The document is a regulatory approval letter, not a performance study report.

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