Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K072722
    Device Name
    MEDDORNA WIRELESS PRN SPIROMETER 100
    Manufacturer
    Date Cleared
    2008-04-24

    (211 days)

    Product Code
    Regulation Number
    868.1840
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDDORNA LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MEDDORNA Wireless PRN Spirometer Model 100 is intended for use as a diagnostic spirometer, measuring FVC, MVV and SVC breathing functions.
    Device Description
    The MEDDORNA Wireless PRN Spirometer 100 is a full featured spirometer allowing Forced Vital Capacity (FVC) spirometry, Maximum Voluntary Ventilation (MVV), and Slow Vital Capacity (SVC) and all spirometry tests will be available, including pre/post bronchodilator testing. The MEDDORNA Wireless PRN Spirometer 100 utilizes wireless interface to a thin client Personal Computer or Internet Server. This allows real-time graphical display and review of the spirometry loop along with alpha character patient entry when desired. The MEDDORNA Wireless PRN Spirometer 100 utilizes pre-calibrated plastic disposable mouthpieces; this negates the need for a 3-liter syringe. The MEDDORNA Wireless PRN Spirometer has a rechargeable battery pack and wireless (Bluetooth) data link output directly to a thin client PC for reporting purposes.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1