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510(k) Data Aggregation

    K Number
    K021185
    Device Name
    NERVUS MONITOR
    Manufacturer
    TAUGAGREINING HF
    Date Cleared
    2002-07-12

    (88 days)

    Product Code
    OLV,GWQ
    Regulation Number
    882.1400
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    NERVUS MONITOR

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

    The Nervus Monitor system is intended to record and process EEG signals from third party transducer such as ECG, EMG, Oxygen Saturation or Respiration, from adult to pediatric patients.

    The Nervus Monitor is intended for use only by medically trained and qualified personnel, within a hospital or medical environment.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) substantial equivalence letter from the FDA for a device called "Nervus Monitor". It states the determination of substantial equivalence to predicate devices and outlines regulatory requirements.

    Specifically, the document does not include:

    1. A table of acceptance criteria and reported device performance.
    2. Details on sample sizes for test sets, data provenance, training sets, or how ground truth was established for either.
    3. Information on the number or qualifications of experts, or any adjudication methods.
    4. Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.

    The document primarily focuses on regulatory approval and classification, not details of a specific performance study.

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