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510(k) Data Aggregation

    K Number
    K241397
    Device Name
    Hinscope
    Manufacturer
    Hinlab SAS
    Date Cleared
    2024-11-14

    (182 days)

    Product Code
    MSX, DQA, DXN
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Hinlab SAS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    hinscope is intended for spot-check vital signs measurement of adult patients in professional healthcare facilities, such as hospitals or skilled nursing facilities. It is intended to be used by trained healthcare professionals. hinscope is intended for spot-check measurements, in adults, of: - Non-Invasive blood pressure (NIBP) - - -Pulse rate (PR) - -Oxygen saturation (SpO2) hinscope is not intended for use in high-acuity environments, such as intensive care units (ICU) or operating rooms. hinscope is not intended for use on acutely ill cardiac patients with the potential to develop life-threatening arrhythmias e.g. very fast atrial fibrillation. These patients should be monitored using a device with continuous electrocardiogram (ECG). hinscope is not a substitute for an ECG monitor. hinscope is not intended for SpO2 and PR measurements in conditions of high motion or low perfusion.
    Device Description
    hinscope consists of the: - hinscope measurement unit - hinscope mobile application hinscope consists of a vital sign measurement unit, that is positioned on the patient's upper arm, and a mobile application with a user interface which allows display of the vital sign data. hinscope is a combination of optical sensors and a sphygmomanometer cuff which provide measurements of the patient's pulse rate (PR) oxygen saturation (SpO2), and non-invasive blood pressure (NIBP). PR and SpO2 are measured using a photoplethysmography (PPG) optical measurement method. PPG is a noninvasive technology that uses light sources (green, red and infrared) and photodetectors at the surface of skin to measure the volumetric variations of blood circulation. Blood pressured with the sphygmomanometer using an algorithm in which the cuff is slowly inflated while simultaneously sensing oscillations are no longer detected, the cuff deflates rapidly, and the signals are processed to determine systolic and diastolic pressures. The vital sign measurement device communicates with a mobile application via wireless Bluetooth Low Energy (BLE) communication. The hinlab mobile application displays the blood pressure, SpO2 and pulse rate measurements.
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