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510(k) Data Aggregation

    K Number
    K213335
    Device Name
    Capsule Surveillance System
    Manufacturer
    Capsule Surveillance Technologies, SAS /Capsule Tech, Inc.
    Date Cleared
    2022-01-14

    (100 days)

    Product Code
    MWI
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Capsule Surveillance Technologies, SAS /Capsule Tech, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Capsule Surveillance is a clinical decision support device that integrates, analyzes, and displays data from multiple sources including medical devices and healthcare information systems. It uses standardized rules that are based on customers approved clinical protocols, and policies to create clinically relevant alerts in health care facilities when used by clinical physicians or appropriate medical staff under the direction of physicians. It is not intended to replace clinicians' judgment, but rather to assist clinicians in making timely, informed, higher quality decisions. Capsule Surveillance may be configured for secondary monitoring and alerting intended to be relied upon in deciding to take immediate clinical action. Capsule Surveillance may also be configured for remote display of physiological data and alerts not intended to be relied upon in deciding to take immediate clinical action.
    Device Description
    The Capsule Surveillance System is a clinical decision support device that integrates data from multiple sources including medical devices and healthcare information systems. The Capsule Surveillance Systems offers two methods of accessing the clinical application: . A workstation which is a dedicated desktop used exclusively to run the Capsule Surveillance System clinical application in kiosk mode. . The remote display which is any machine that accesses the Capsule Surveillance System via a web browser. Use of the Capsule Surveillance System allows for simultaneous monitoring of different patients in a clinical setting, providing information from integrated data sources that monitor physiological parameters such as, pulse, respiratory rate, SpO2, temperature, and blood pressure.
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