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510(k) Data Aggregation

    K Number
    K050098
    Device Name
    DDAT OMT
    Manufacturer
    DDAT(UK) LTD
    Date Cleared
    2005-05-23

    (125 days)

    Product Code
    GWN
    Regulation Number
    882.1460
    Why did this record match?
    Applicant Name (Manufacturer) :

    DDAT(UK) LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DDAT OMT is intended to be used to observe, record and measure eye movements in patients during ocular motor testing. The DDAT OMT is intended for use by qualified medical personnel trained in the use of nystagmographs.
    Device Description
    The DDAT OMT is a computer based medical device comprising of a Computer, a Display Monitor for viewing eye movements, a Lightbar which provides the stimulus for the eye movement and a client amplifier that tracks the patient's eye movement.
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