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510(k) Data Aggregation

    K Number
    K020400
    Device Name
    DIGITIMER D185 MULTIPULSE CORTICAL STIMULATOR
    Manufacturer
    MEPS, LLC.
    Date Cleared
    2002-08-23

    (198 days)

    Product Code
    GWF
    Regulation Number
    882.1870
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEPS, LLC.

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

    The Digitimer D185 is used for the intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device called the "Digitimer D185 Multipulse Cortical Stimulator." This document confirms the device's clearance for marketing based on substantial equivalence to a predicate device.

    It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies (MRMC or standalone).

    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.

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