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510(k) Data Aggregation

    K Number
    K050104
    Device Name
    APEX MEDICAL MININEB & MINIPLUS
    Manufacturer
    APEX MEDICAL CORP.
    Date Cleared
    2005-02-16

    (29 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Type
    Special
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The 9R-02X Series, MiniNeb & MiniPlus are designed to provide a compressed air source to aerosolize physician-prescribed liquid medication when used in combination with the packaged Salter Labs 8900 series nebulizer, except for Pentamidine

    Device Description

    9R-02X Series, MiniNeb & MiniPlus

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a nebulizer device. It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

    The letter focuses on:

    • Confirming that the device (9R-02X Series, MiniNeb & MiniPlus) is substantially equivalent to legally marketed predicate devices.
    • Outlining the regulatory requirements that the manufacturer must adhere to (e.g., annual registration, listing, good manufacturing practices, labeling).
    • Stating the intended use of the device.

    Therefore, I cannot provide the requested information based on the input text. The document is solely a regulatory clearance communication, not a technical report detailing performance studies.

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