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510(k) Data Aggregation

    K Number
    K961638
    Device Name
    MEDILOG MPA-S
    Manufacturer
    OXFORD INSTRUMENTS MEDICAL SYSTEMS
    Date Cleared
    1997-01-17

    (263 days)

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

    MEDILOG MPA-S

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

    Recording of a physiological signals (single channel of EEG, and or recording of ECG signals at 64 Hz) that are required to aid in the diagnoses of sleep related disorders.

    Device Description

    Medilog MPA-S Recorder

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device called the "Medilog MPA-S Recorder." This document primarily addresses regulatory approval and does not contain information about acceptance criteria, study methodologies, or performance data for the device.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document is a regulatory approval letter, not a scientific study report.

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