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510(k) Data Aggregation

    K Number
    K042349
    Device Name
    EMG MODEL SUA01 SUCTION UNIT
    Manufacturer
    EMG TECHNOLOGY CO., LTD.
    Date Cleared
    2004-12-16

    (108 days)

    Product Code
    JCX
    Regulation Number
    878.4780
    Type
    Abbreviated
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    EMG MODEL SUA01 SUCTION UNIT

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

    The Model SUA01 Suction unit is intended for professional use to remove infectious materials from wounds or fluids from a patients airway or respiratory support unit. The intended large population for this device is both adult and pediatric patients.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria, study details, or device performance metrics for the "Model SUA01 Suction Unit". The document is a 510(k) clearance letter from the FDA, which determines substantial equivalence to a predicate device and allows the device to be marketed. It states the indications for use but does not contain a study report or technical specifications with performance data.

    Therefore, I cannot provide the requested table and study details.

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