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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
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEPS, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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
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