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510(k) Data Aggregation

    K Number
    K963195
    Device Name
    WIRELESS EEG RECORDING SYSTEM MODEL W32
    Manufacturer
    CME TELEMETRIX, INC.
    Date Cleared
    1997-07-29

    (348 days)

    Product Code
    GYE84G
    Regulation Number
    882.1855
    Why did this record match?
    Product Code :

    GYE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Wireless EEG Recording System Model W32 is intended to amplify, filter and convert into digital values electrophysiological voltages (primarily EEG, EOG, EMG, and ECG) sensed by conventional skin surface electrodes which have been attached to the patient. These signals are then transmitted via radio waves to the receiver portion of the system which transfers them to a computer for display and evaluation by appropriate health professionals.
    Device Description
    Not Found
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    K Number
    K970659
    Device Name
    DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVER
    Manufacturer
    TELEDIAGNOSTIC SYSTEMS, INC.
    Date Cleared
    1997-05-16

    (84 days)

    Product Code
    GYE
    Regulation Number
    882.1855
    Why did this record match?
    Product Code :

    GYE

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