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510(k) Data Aggregation

    K Number
    K220111
    Device Name
    RespiraSense
    Manufacturer
    PMD Solutions
    Date Cleared
    2022-10-07

    (267 days)

    Product Code
    BZQ, BOZ
    Regulation Number
    868.2375
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    Applicant Name (Manufacturer) :

    PMD Solutions

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RespiraSense is indicated for continuous, non-invasive, and real-time monitoring of respiratory rate. RespiraSense is indicated for patients 18 years and older in hospital-type facilities and while patients are mobile (e.g., walking). RespiraSense is not intended to be an apnoea monitor.
    Device Description
    The RespiraSense (RS) monitors respiratory rate by directly measuring displacements of the chest and abdomen that occur during breathing which are analogous of respiratory rate. This is measured using piezoelectric film elements that output a varying voltage when displaced. The RS device is a non-invasive, wireless, respiratory rate (RR) monitor that is worn on the body of the patient. It is internally-powered, and enables continuous RR monitoring from a single application for up to four days. It is designed to enhance the ability of medical staff to reliably measure respiratory rate remotely. The RS Device is comprised of the RespiraSense Lobe (hereafter the Lobe), the reusable component that houses the RS Device's electronics, a single use adhesive RespiraSense Sensor (hereafter the Sensor) and Cradle. The Lobe and Sensor connect via a secured flat cable and are mechanically fastened together using a plastic Cradle. The Lobe and Sensor are placed on the left-hand side of a patient's torso. The Lobe transmits wirelessly via Bluetooth to an iPad running PMDs RS App for display, control and alert functionality. The RS App allows for Configuring the Lobe, Displaying respiration rate, Display SpO2 and Pulse rate from a connected Nonin device (optional), Configuring alert limits. The RS application can also connect to and display information from multiple Lobes simultaneously. The Lobe is rechargeable. It is designed to be charged using the supplied Charging Station. Charging must be done outside of the immediate patient environment. Charging cannot occur while the device is in operation. Up to six Lobes can be charged at one time. The Sensor is the only patient-contacting device and is secured to the patient with medical grade adhesive.
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