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    K Number
    K071733
    Device Name
    DL900 SERIES HOLTER RECORDER
    Manufacturer
    BRAEMAR, INC.
    Date Cleared
    2007-07-24

    (28 days)

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

    DL900 SERIES HOLTER RECORDER

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

    The DL900 Series Holter Recorder is intended for patients requiring ambulatory (Holter) monitoring. Such monitoring is most frequently used for the indications below:

    • Evaluation of symptoms suggesting arrhythmia or myocardial ischemia.
    • Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients.
    • Evaluation of patients for ST segment changes.
    • Evaluation of a patient's response after resuming occupational or recreational activities (e.g., after M.I. or cardiac surgery.)
    • Clinical and epidemiological research studies.
    • Evaluation of patients with pacemakers.
    • Reporting of time and frequency domain heart rate variability.
    • Reporting of QT Interval
    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about the acceptance criteria for the Braemar DL900 Series Holter Recorder or any studies conducted to prove the device meets such criteria. The document is an FDA 510(k) clearance letter confirming that the device is substantially equivalent to a legally marketed predicate device for its stated indications for use.

    Therefore, I cannot fulfill your request for the specific details regarding acceptance criteria and supporting studies.

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