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510(k) Data Aggregation

    K Number
    K012415
    Device Name
    AURIS AEP
    Manufacturer
    Date Cleared
    2001-12-18

    (141 days)

    Product Code
    Regulation Number
    882.1900
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYNAPSYS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The AURIS I and AURIS II ABR Systems provide information regarding the functional integrity of the peripheral and central auditory system. It tests for auditory evoked potentials as an aid in detecting hearing loss and lesions in auditory pathways. It is ittended for use in the recording and analysis of human physiological data necessary for the diagnosis of auditory and hearing-related disorders.
    Device Description
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    K Number
    K982103
    Device Name
    ULMER (VNG) VIDEO NYSTAGMOGRAPH
    Manufacturer
    Date Cleared
    1998-09-11

    (88 days)

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

    SYNAPSYS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Ulmer Video Nystagmograph System is intended for use by the physician as an aid for the detection and diagnosis of vestibular disorders. The Ulmer VNG detects and displays eye position and movement in response to a number of vestibular stimulations, i.e. saccadic test, smooth pursuit, optokinetic nystagmus, caloric tests, and kinetic vestibular tests. The Ulmer VNG records and analyzes the bilateral, monocular, horizontal, and vertical aspects of eye position and movement. This device is intended to be used in a doctor's office or health care facility to obtain recorded data of nystagmus by directly observing eye motion by videocameras. The resulting recorded data is evaluated by a trained physician and considered along with other relevant data in diagnosing vestibular disorders.
    Device Description
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