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510(k) Data Aggregation

    K Number
    K042469
    Device Name
    BRAEMAR ER800 SERIES ENHANCED ALGORITHM EVENT RECORDER
    Manufacturer
    BRAEMAR, INC.
    Date Cleared
    2004-10-06

    (23 days)

    Product Code
    MWJ
    Regulation Number
    870.2800
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BRAEMAR ER800 SERIES ENHANCED ALGORITHM EVENT RECORDER

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

    The device is indicated for diagnostic evaluation of patients who experience transient symptoms such as; dizziness, palpitations, syncope, or chest pain. The device is intended to record cardiac activity associated with these infrequent and transient symptoms. Once data is recorded, patients transmit the recorded ECG data over the telephone or directly to a host PC for review by a licensed physician.

    Device Description

    Braemar ER800 Series Enhanced Algorithm Event Recorder

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the Braemar ER800 Series Enhanced Algorithm Event Recorder. It does not contain information about acceptance criteria, device performance, study details, or ground truth establishment.

    Therefore, I cannot provide the requested information based on the provided text. The document is an administrative clearance and does not include technical or clinical study data.

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