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510(k) Data Aggregation
K Number
K230501Device Name
Spirobank Oxi
Manufacturer
MIR Medical International Research USA
Date Cleared
2023-12-15
(294 days)
Product Code
BZG, DQA
Regulation Number
868.1840Why 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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