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510(k) Data Aggregation

    K Number
    K103530
    Device Name
    SPIRODOC
    Manufacturer
    MEDICAL INTERNATIONAL RESEARCH USA, INC.
    Date Cleared
    2011-11-21

    (355 days)

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

    MEDICAL INTERNATIONAL RESEARCH USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Spirodoc Spirometer and pulse oximeter is intended to be used by a physician or by a patient under the prescribed use of a physician. The device is intended to test lung function and can perform spirometry testing in adult and pediatric patients, excluding infants and neonates, and oximetry readings in patients of all ages.
    Device Description
    Spirodoc is a pocket-size spirometer and oximeter. The device is made up of: - a central unit which measures and collects information related to the state of health of the patient, with wireless or cable transmission of the collected data using a microprocessor based system with a touch screen display, USB communication port and Bluetooth, . - a removable sensor for the measurement of respiratory air flow and volume, ﮯ - a removable pulse oximetry sensor - Stored data can be then delivered through landline, broadband, wireless and cell-phone technology to be received by a web server and can then be accessed by medical staff.
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