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510(k) Data Aggregation

    K Number
    K172271
    Device Name
    Trackit T4 EEG Amplifier
    Manufacturer
    Lifelines Ltd.
    Date Cleared
    2018-05-04

    (280 days)

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

    Lifelines Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Trackit T4 EEG Amplifier is intended to be used as a front-end amplifier to acquire, store and transmit electrophysiological signals (wireless or cabled).
    Device Description
    The Trackit T4 EEG Amplifier is a multi-channel electroencephalograph designed for use in routine EEG and lab monitoring applications and due to its small size, can be used in ambulatory applications. In this situation, the EEG electrodes are fitted to the patient by a trained clinician prior to the patient being sent home. No subsequent intervention is required by the patient. Upon completion of the recording, the data which is stored on a memory card is reviewed by a clinician using review and analysis software on a PC. It is a compact USB amplifier which provides 32 channels with internal expansion option) with built-in calibration and electrode impedance measurement. Also provided is a Nonin pulse oximeter interface, a Patient Event input and an Aux DC input. Optional wireless communication is available (Bluetooth and WLAN WiFi). There are two variants of the Trackit T4 EEG Amplifier: - Trackit T4-32 providing 24 referential + 8 poly channels. . - . Trackit T4-68 providing 64 referential + 4 poly channels (using internal expansion board). Plug-on Patient Connection Units (PCUs) provide 32 channel touchproof inputs (model T4-PCU 24+8) or 68 channels (model T4-PCU 64+4). The Amplifier is intended to be connected to a USB port on a PC which is powered from a medically approved power supply. In addition it can be battery powered in ambulatory applications. This equipment is intended only as an adjunct device in patient assessment; it must be used in conjunction with other methods of patient diagnosis. The equipment does not sustain or support life.
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    K Number
    K151600
    Device Name
    R-40 EEG Amplifier
    Manufacturer
    LIFELINES LTD.
    Date Cleared
    2015-10-23

    (133 days)

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

    LIFELINES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The R-40 EEG Amplifier is intended to be used as a front-end amplifier to acquire, store and transmit electrophysiological signals (wireless or cabled).
    Device Description
    The R-40 EEG Amplifier is a multi-channel electroencephalograph designed for use in routine EEG and lab monitoring applications. It is a compact USB 40-channel amplifier which incorporates 32 referential channels and 8 polygraphic channels with built-in calibration and electrode impedance measurement. A Nonin pulse oximeter interface is provided, a Patient Event input, 2 Aux DC inputs and an Electrocap connector. Optional wireless communication is available (Bluetooth and WLAN WiFi). The Amplifier is intended to be connected to a USB port on a PC which is powered from a medically approved power supply. This equipment is intended only as an adjunct device in patient assessment; it must be used in conjunction with other methods of patient diagnosis. The equipment does not sustain or support life.
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    K Number
    K101691
    Device Name
    LIFELINES PHOTIC STIMULATOR
    Manufacturer
    LIFELINES LTD.
    Date Cleared
    2010-08-10

    (55 days)

    Product Code
    GWE, DEV
    Regulation Number
    882.1890
    Why did this record match?
    Applicant Name (Manufacturer) :

    LIFELINES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lifelines Photic Stimulator is indicated for photic activation of the EEG during an EEG study and in the generation of visual evoked potentials.
    Device Description
    The Photic Stimulator is a device for generating short-duration flashes of white light by means of a solid-state LED (light emitting diode). The flashes are controlled from a host PC and typically occur over a repetition rate of between 1 and 60Hz.
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    K Number
    K010460
    Device Name
    LIFELINES TRACKIT
    Manufacturer
    LIFELINES LTD.
    Date Cleared
    2001-05-14

    (87 days)

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

    LIFELINES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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