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510(k) Data Aggregation

    K Number
    K161062
    Device Name
    NR Recorder
    Manufacturer
    Norav Medical GmbH
    Date Cleared
    2016-06-13

    (59 days)

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

    Norav Medical GmbH

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

    The NR recorder is intended for patients requiring: · Ambulatory (Holter) monitoring · Use within the physician office setting by the medical professional ECG monitoring (using Bluetooth communication) - Resting - Telemetry ECG monitoring (using Bluetooth communication) 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 activities (for example, after myocardial infarction 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

    NR Recorder

    AI/ML Overview

    This FDA 510(k) clearance letter (K161062) for the Norav Medical GmbH NR Recorder does not contain the detailed information required to describe the acceptance criteria and the study proving the device meets those criteria.

    The document primarily focuses on:

    • Approval of the 510(k) submission: Stating that the device is substantially equivalent to legally marketed predicate devices.
    • Regulatory compliance: Reminding the company of general controls provisions and other applicable regulations (e.g., registration, listing, labeling, adverse event reporting, good manufacturing practice).
    • Indications for Use: Describing the intended clinical applications for the NR Recorder.

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

    To fulfill your request, I would need a more detailed technical document, such as the full 510(k) summary or an associated clinical/performance study report submitted by Norav Medical GmbH to the FDA. These documents typically contain the specific performance metrics, study designs, sample sizes, and ground truth methodologies used to validate the device.

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