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510(k) Data Aggregation

    K Number
    K171397
    Device Name
    Sienna Ultimate Wireless Amplifier
    Date Cleared
    2017-10-06

    (148 days)

    Product Code
    Regulation Number
    882.1835
    Why did this record match?
    Applicant Name (Manufacturer) :

    EMS Handels Gesellschaft m.b.H.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Sienna Ultimate EEG amplifier is intended to be used as a front end amplifier to acquire, store and transmit electrophysiological signals in a wired or wireless mode for the EMS Neurodiagnostic system.
    Device Description
    The Sienna Ultimate is a small portable device which is capable of acquiring a variety of electrophysiological signals at variable sampling frequencies and can be used in a wide variety of EEG applications. The proposed device consists of two models designated as the 32 channel and the 64 channel amplifier in a wireless or wired mode, passive headboxes, medical grade power supply, WLAN access point (for wireless models) or medical grade isolated LAN cable (for wired models), Sienna EEG software. The following accessories can be connected to the passive headboxes: EEG electrodes, EEG headcaps and pulse oximeter sensors.
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