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510(k) Data Aggregation

    K Number
    K021807
    Device Name
    GRASS-TELEFACTOR AS40 AMPLIFIER SYSTEM
    Manufacturer
    GRASS INSTRUMENT CO.
    Date Cleared
    2002-08-29

    (87 days)

    Product Code
    OLV, GWQ
    Regulation Number
    882.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    GRASS INSTRUMENT CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AS40 amplifier system is designed for use in the recording of routine EEG, overnight sleep/EEG (PSG, Polysomnography), and other neurophysiological monitoring applications (EMG and Evoked Potentials). This device is intended to be used only by physicians, technicians, or other medical professionals that are trained in either electroencephalography or polysomnography.
    Device Description
    The AS40 is a compact 40-channel AC amplifier unit designed for electroencephalography and polysomnography recording applications. The AS40 provides for patient safety isolation, signal conditioning (physiological signal amplification and filtering), and digitization. Communications with a single host computer are accomplished using TCP/IP protocol over a 10BaseT Ethernet network or dedicated cable. A host computer, using the appropriate software, sets the sample rate, starts and stops the data transmission, monitors the digital data, and stores it to hard disk.
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    K Number
    K994142
    Device Name
    GRASS TS3201/6401 EEG AMPLIFIER SYSTEM
    Manufacturer
    GRASS INSTRUMENT CO.
    Date Cleared
    2000-03-06

    (89 days)

    Product Code
    OLV, GWQ
    Regulation Number
    882.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    GRASS INSTRUMENT CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TS3201/6401 amplifier system is designed for use in the recording of routine EEG, long-term EEG with patient video and overnight sleep/EEG recording applications (Polysomnography). This device is intended to be used only by physicians, technicians, or other medical professionals that are trained in electroencephalography.
    Device Description
    The Grass TS3201/TS6401 systems are 32-channel and 64-channel (respectively) devices for acquiring and conditioning EEG signals and transmitting them to a personal computer for display and storage. The system consists of one or more miniature pager-size 32channel preamplifier units, which plug into a small "belt-pack" designed to be worn by the patient. The belt-pack provides further signal conditioning, safety isolation and communication to a remotely located interface panel and data acquisition computer. Up to two TS3201 or TS6401 belt-packs, in any combination, can be plugged into the interface panel to provide for up to 128 channels of EEG monitoring from a single subject. Each belt-pack includes one additional pair of inputs for standard electrodes for monitoring EOG (eye movement) or ECG. Additionally, each belt-pack also includes a patient call pushbutton, which can be used to signal the control room or automatically trigger event marks or recording devices.
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