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510(k) Data Aggregation

    K Number
    K043238
    Date Cleared
    2005-07-06

    (226 days)

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

    COMPRESSOR NEBULIZER, MODEL EMG NBA02-XXX SERIES

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

    The EMG NBA02-XXX Series Compressor Nebulizer is a compact medical nebulizing device intended for professional use containing a compressor and medical nebulizer used as prescribed by a physician for medication in the home or health care facility.

    Device Description

    The EMG NBA02-XXX Series Compressor Nebulizer is a compact medical nebulizing device intended for professional use containing a compressor and medical nebulizer.

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA to EMG Technology Company Limited regarding their EMG NBA02-XXX Compressor Nebulizer. It states that the device has been found substantially equivalent to legally marketed predicate devices and can be marketed.

    This document does not contain information about acceptance criteria or a study proving that the device meets those criteria. It is a regulatory approval document, not a scientific study or performance report. Therefore, I cannot extract the requested information from the provided text.

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