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510(k) Data Aggregation

    K Number
    K223681
    Manufacturer
    Date Cleared
    2023-03-08

    (90 days)

    Product Code
    Regulation Number
    868.2375
    Reference & Predicate Devices
    Why did this record match?
    Reference Devices :

    K151940

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Respiree Cardio-Respiratory Monitor is a respiratory monitor intended for hospital-type facilities in non-ICU settings. The Respiree Cardio-Respiratory Monitor is indicated for the non-invasive spot checking of respiration rate (RR) for adult patients.

    Device Description

    The Respiree Cardio-Respiratory Monitor, Model RS001, is a small respiratory monitor. For measurement of respiration rate (RR), the device is affixed to the chest using a disposable adhesive patch with a hook-and-loop fastener to attach to the monitor. The device uses a vertical-cavity surface-emitting diode to emit optical radiation directed toward the skin. An integrated photodetector in a nearby position senses the diffused collected light. An adaptive signal processing method is used to enhance the device respiratory rate measurements by splitting the signal processing optimizations across different respiratory rate bands.

    The monitor is powered by a 3.7V rechargeable, lithium-ion battery and a USB charging cable is provided. The Respiree Cardio-Respiratory Monitor also includes optional Bluetooth wireless technology for the wireless transfer of patient data to mobile devices.

    AI/ML Overview

    Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Performance MetricAcceptance Criteria (Predicate)Reported Device Performance (Respiree Cardio-Respiratory Monitor)
    Performance range5 - 60 rpm5 - 50 rpm
    Accuracy (ARMS)
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