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510(k) Data Aggregation

    K Number
    K172329
    Device Name
    Patient Status Engine
    Manufacturer
    Isansys Lifecare Ltd
    Date Cleared
    2018-04-23

    (264 days)

    Product Code
    DRG
    Regulation Number
    870.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    Isansys Lifecare Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Patient Status Engine is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of physiological data in home and healthcare settings. This includes heart rate, heart rate variability (R-R interval), ECG derived respiration rate data (EDR), skin temperature, activity, posture and optional SpO2 and non-invasive Blood Pressure (BP). Data is transmitted wirelessly from the sensors to the Patient Gateways and from the Patient Gateways to a central Server where it is stored for analysis. The Patient Status Engine can include the ability to notify healthcare professionals when physiological data fall outside selected parameters. The device is intended for use on general care patients who are 18 years of age or older as a general patient monitor, to provide physiological information. The data from the Patient Status Engine is intended for use by healthcare professionals as an aid to diagnosis and treatment. It is not intended for use on critical care patients nor replace standard monitoring and/or routine care.
    Device Description
    The Patient Status Engine (PSE2) is a wireless data collection system that monitors physiological data and consists of the following components / subsystems and optional third party devices as listed below: Components and Subsystems: Patient Gateway (Samsung Tablet) – Manufactured by Samsung Patient Gateway Software – Manufactured by Isansys Lifecare Ltd Lifetouch Blue Sensor – Manufactured by Isansys Lifecare Ltd Lifetemp Sensor– Manufactured by Isansys Lifecare Ltd Lifeguard Server Software – Manufactured by Isansys Lifecare Ltd Additional third party Accessories: Pulse Oximeter 3150– Manufactured by Nonin Blood Pressure Monitor UA767– Manufactured by A&D Medical Skintact ECG Electrodes – Manufactured by Leonhard Lang Ambu White Sensors – Manufactured by Ambu Inc. At the subsystem level the Patient Gateway, Lifetouch Blue Sensor and Lifetemp Sensor are collectively identified as the Patient Digitisation Engine (PDE2). The inclusion of the Lifeguard Server completes the Patient Status Engine (PSE2).
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