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510(k) Data Aggregation

    K Number
    K070990
    Device Name
    APEX MEDICAL MOBINEB, 9R-027 SERIES
    Manufacturer
    APEX MEDICAL CORP.
    Date Cleared
    2007-05-18

    (39 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-027XXX Series, MobiNeb 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

    Not Found

    AI/ML Overview

    This document is primarily a 510(k) clearance letter from the FDA for a nebulizer. It does not contain information about acceptance criteria or a study proving the device meets said criteria. Therefore, I cannot provide the requested information based on the provided text.

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