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510(k) Data Aggregation

    K Number
    K130288
    Device Name
    STEALTH MONITOR, STEALTH DOCKING CABLE, STEALTH DISPLAY AND STORAGE DEVICE
    Manufacturer
    CARDIAC INSIGHT, INC.
    Date Cleared
    2013-05-29

    (113 days)

    Product Code
    DSH
    Regulation Number
    870.2800
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    K142468
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Stealth™ Monitor is a prescription only single use, continuous recording ECG monitor that can be worn up to least 24 hours. It is indicated for use with patients where it would be desirable to record ECG signals for this period of time.

    Device Description

    Stealth™ Monitor, Docking Cable and Display and Storage Device

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA to Cardiac Insight Inc. for their Stealth™ Monitor. This document, while indicating the device's regulatory approval, does not contain the detailed information required to answer the request about acceptance criteria, study findings, and ground truth establishment for a device study.

    Specifically, the document focuses on regulatory approval and equivalence to predicate devices, rather than providing a performance study report.

    Therefore, I cannot extract the requested information from the provided text.

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