Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K990506
    Device Name
    MABIS NB-02 ULTRASONIC NEBULIZER
    Manufacturer
    MABIS HEALTHCARE, INC.
    Date Cleared
    1999-03-11

    (22 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    MABIS HEALTHCARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MABIS NB-02 is an ultrasonic nebulizer intended for use in the treatment of asthma, COPD, and other respiratory ailments in which an aerosolized medication is required during therapy. It may be necessary to perform respiratory therapy at anytime and anywhere the patient needs it. The MABIS NB-02 nebulizer is not intended for use with Pentamidine. It is intended for single patient use.
    Device Description
    MABIS NB-02 Ultrasonic Nebulizer
    Ask a Question

    Page 1 of 1