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510(k) Data Aggregation

    K Number
    K990522
    Device Name
    WARATAH DIGITAL EEG AND SLEEP ACQUISITION DEVICES WITH, OR WITHOUT, PULSE OXIMETRY,CARDINAL DIGITAL EEG AND SLEEP ACQUIS
    Manufacturer
    LA MONT MEDICAL, INC.
    Date Cleared
    1999-05-19

    (90 days)

    Product Code
    OLV,GWQ
    Regulation Number
    882.1400
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K990522
    Why did this record match?
    Applicant Name (Manufacturer) :

    LA MONT MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    • For long term unattended EEG or other electrophysiological sigmal monitoring and recording.
    • This device is intended for use by physicians skilled in alectroencephalography. These individuals are typically Board Certified Neurologists or Neurophysiologists or the equivalent or Ph.D. level Electroencephalographers.
    • We recommend placement of electrodes in accordance with the 10.20 International System.
    Device Description

    DigitaEEG and Sleep Acquisition System With or Without Pulse Oximetry Function

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, validation studies, sample sizes, expert qualifications, or ground truth. The document is an FDA 510(k) clearance letter for a medical device called "DigitaEEG and Sleep Acquisition System With or Without Pulse Oximetry Function", confirming its substantial equivalence to a predicate device. It discusses regulatory matters and indications for use but does not delve into the detailed technical performance or validation studies of the device.

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