LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K041485
    Device Name
    MARPAC MESSENGER MODEL #501
    Manufacturer
    MARPAC, INC.
    Date Cleared
    2004-08-02

    (59 days)

    Product Code
    JOH
    Regulation Number
    868.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    MARPAC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Marpac Messenger™ attaches to standard 15mm tracheostomy tubes and assists tracheostomy patients with speech by managing airflow.
    Device Description
    The Marpac Messenger™ consists of a plastic outer body with an inner flexible diaphragm made of medical grade silicone. The Marpac Messenger™ attaches to the hub of a standard 15mm tracheostomy tube. The one-way valve design of the Marpac Messenger™ allows airflow into the valve when the tracheostomy patient inhales and maintains a closed position during expiration thereby directing airflow up through the larynx, mouth, and nose enabling speech.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1