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510(k) Data Aggregation

    K Number
    K081444
    Device Name
    BRAEMAR FUSION WIRELESS - AMBULATORY ECG ARRHYTHMIA MONITORING SYSTEM
    Manufacturer
    BRAEMAR, INC.
    Date Cleared
    2008-07-31

    (70 days)

    Product Code
    DSI,DRG
    Regulation Number
    870.1025
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BRAEMAR FUSION WIRELESS - AMBULATORY ECG ARRHYTHMIA MONITORING SYSTEM

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

    The device is intended for diagnostic evaluation of patients who experience transient symptoms that may suggest cardiac arrhythmia. The device continuously monitors, automatically generates an alarm triggered by an arrhythmia detection algorithm or manually by the patient, and automatically transmits the recorded cardiac activity associated with these symptoms for review by a licensed physician.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for the Braemar Fusion Wireless Ambulatory ECG Arrhythmia Monitor System. It does not contain information about acceptance criteria or the study that proves the device meets them. It primarily states that the device is substantially equivalent to a predicate device and can thus be marketed.

    Therefore, I cannot provide the requested information based on the provided text.

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