Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K213754
    Device Name
    SpiroHome Personal, SpiroHome Clinic
    Manufacturer
    Inofab Saglik Teknolojileri A.S
    Date Cleared
    2023-06-12

    (559 days)

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

    Inofab Saglik Teknolojileri A.S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SpiroHome is intended to be used by adults and children over 5 years old in physician's offices, clinics and home setting to conduct basic lung function and spirometry testing.
    Device Description
    The SpiroHome Ultrasonic Spirometer (SUS) is a portable spirometer designed to perform pulmonary function tests in patients over the age of 5 in office (clinical) and home settings. The SpiroHome spirometer is used together with a SpiroWay mouthpiece that is inserted into and lines the entire airway of the device. SpiroHome derives pulmonary function data from airflow measurements taken by its ultrasonic sensors during a spirometry test. All of the information recorded by the device is displayed on the relevant SpiroHome app running on a Bluetoothconnected device. The pulmonary function test (PFT) data recorded by the SpiroHome device during a spirometry test is also compared against the patient's predicted values which are obtained from internationally accepted PFT equations. The user interfaces with the SpiroHome app during the entire use of the SpiroHome spirometer. The associated accessories include: SpiroWay mouthpiece
    Ask a Question

    Page 1 of 1