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510(k) Data Aggregation

    K Number
    K990660
    Device Name
    NMT NEUROSCIENCES CONTROL UNIT, MODEL 910-600 & NMT NEUROSCIENCES DISPOSABLE DRAINAGE LINE KIT, MODEL 910-6XX
    Manufacturer
    NMT NEUROSCIENCES IMPLANTS S.A.
    Date Cleared
    1999-09-23

    (206 days)

    Product Code
    JXG
    Regulation Number
    882.5550
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Control Unit: The NMT Neurosciences Control Unit is a portable, programmable system, designed for use with the NMT Disposable Drainage Line Kit, that controls cerebrospinal fluid (CSF) external drainage at the programmed pressure. Unlike other external drainage devices, the pressure setting is not dependent upon the patient's position. The system also allows for CSF sampling, collection, and for CSF pressure monitoring.

    Disposable Drainage Line Kit: The Disposable Drainage Line Kit is designed to be connected to the NMT Neurosciences Control Unit for cerebrospinal external drainage, sampling, collection and pressure monitoring.

    Device Description

    Control Unit Disposable Drainage Line Kit

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called "Control Unit Disposable Drainage Line Kit." It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. It is a regulatory approval document confirming substantial equivalence to a predicate device.

    Therefore, I cannot provide the requested information. The input document is a regulatory approval letter and does not include performance data, study results, or detailed acceptance criteria for the device itself.

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