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510(k) Data Aggregation

    K Number
    K230501
    Device Name
    Spirobank Oxi
    Manufacturer
    MIR Medical International Research USA
    Date Cleared
    2023-12-15

    (294 days)

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

    MIR Medical International Research USA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Spirobank Oxi Spirometer and Pulse Oximeter is intended to be used by a physician or by a patient under the prescribed use of a physician. The equipment is intended to test lung function and can perform tests in adult and pediatric patients greater than 5 years. When used as Oximeter, the Spirobank Oxi is intended for spot-checking of functional oxygen saturation of arterial haemoglobin (SpO2) and Pulse Rate (PR) from the patient finger. The Spirobank Oxi has been designed for use in the physician's office, in hospital, or directly by the patient to monitor her/his physical conditions at home.
    Device Description
    Spirobank Oxi 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, using a microprocessor based system. It operates via a Bluetooth connection - a removable sensor for the measurement of respiratory air flow and volume, - a pulse oximetry sensor using reflective technology. - The device is powered by two AAA alkaline batteries. Spirometry: the device is equipped with a plastic mouthpiece connected to a turbine flow meter based on the infrared interruption principle. The device detects the signals generated by the turbine, and measures flow and volume. At the end of the expiration, the device calculates the respiratory parameters. Oximetry: the device measures functional oxygen saturation of arterial haemoglobin (SpO2) and pulse rate (PR) by means of a reflective light sensor. Specifically, it uses a two-wavelength sensor to measure the indicated parameters based on light reflection principles of oxygenated blood and deoxygenated blood, which generates a photoplethysmogram. From the photoplethysmogram the device calculates SpO2 and PR Spirobank Oxi connects via Bluetooth to a device (PC, tablet or smartphone) which allows to insert patient data, perform spirometry manoeuvres and oximetry tests, as well as display the results, including the relative graphs.
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    K Number
    K181666
    Device Name
    Smart One
    Manufacturer
    MIR Medical International Research
    Date Cleared
    2018-08-01

    (37 days)

    Product Code
    BZH
    Regulation Number
    868.1860
    Why did this record match?
    Applicant Name (Manufacturer) :

    MIR Medical International Research

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Smart One is intended for home use by patients to monitor PEF (Peak Expiratory Flow) and FEVI (Forced Expiratory Volume in one second). The device is designed for children greater than five years of age, adolescent and adult subjects.
    Device Description
    Smart One is a pocket-sized system for monitoring the following respiratory parameters: PEF (Peak Expiratory Flow) and FEV1 (Forced Expiratory Volume in 1 sec). For each of these two parameters, the result is a number shown on the smartphone screen. PEF is also associated with a three zone monitoring system that, according to the result, may be green, yellow or red. Smart One is made up of two elements - the device and a Mobile Medical Application for smartphones (or tablets) that communicate via Bluetooth Smart 4.0.
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