Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K120880
    Device Name
    ORBIT
    Date Cleared
    2012-04-19

    (27 days)

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

    NATIONAL BIOMEDICAL LLC DBA QRS DIAGNOSTIC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    - Device Functionality: Spirometry . - Primary Spirometric Parameters: FVC, MVV, SVC and FEF . - Patient Population: Male/Female, Pediatric to Adult . - Environment of Use: Hospital, Clinic and Home Use under trained professional supervision (Prescription Use) The QRS Diagnostic Orbit Spirometer is intended for the acquisition, analysis, display and print of measurements and waveforms of pulmonary function for the purposes of assily any clinicians in the diagnosis of various pulmonary function diseases and/or treatment regimens.
    Device Description
    The QRS Orbit product model Z-7000-0101 consisting of a spirometer, pressure tube, disposable pneumotachometer, Office Medic Software and a host computer is a compact and versatile personal computer (PC) based pulmonary function analyzer (spirometer). The product measures a patient's expiratory and inspiratory airflow, analyzes the data with print options that includes the measured and predicted values and flow vs. volume or volume vs. time graphs. The Orbit spirometer includes the following components: - . Spirometer - Spirometer Pressure Tube . - Disposable pneumotachometer (mouthpiece) - Office Medic Software . - Host PC (User Provided) .
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1