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510(k) Data Aggregation

    K Number
    K042923
    Device Name
    MD-6W WIRELESS CRITICAL DATA VIEWER
    Date Cleared
    2004-12-17

    (56 days)

    Product Code
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    THE MICROOPTICAL CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MD-6W Wireless Critical Data Viewer is intended to display patient vital signs in such a way that the data is continuously in a medical specialist's field of view. A typical application would be to view the vital signs of a patient undergoing surgery.
    Device Description
    The MD-6W Wireless Critical Data Viewer contains a mobile viewer (consisting of an LCD display unit, non-prescription safety glasses, and a control box with signal converter and lithium-ion rechargeable battery) and a base station that connects via cable to a patient monitor. The LCD display unit is mounted on the non-prescription safety glasses and is connected via a four-foot cable to the control box. The control box receives signal via wireless telemetry from the base station. The battery is recharged using a separate battery charger.
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    K Number
    K040244
    Device Name
    MICROOPTICAL'S CRITICAL DATA VIEWERS, MODELS MD-3 AND MD-6
    Date Cleared
    2004-03-24

    (50 days)

    Product Code
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    THE MICROOPTICAL CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    MicroOptical's Critical Data Viewers are intended to display video images or patient data while mounted in front of the user's eye(s) anytime a video display is used. Typical applications include display of images from endoscopic cameras, ultrasound imaging systems, magnetic resonance imaging systems, or display of data from any type of patient monitor.
    Device Description
    MicroOptical's Critical Data Viewers contain an LCD display unit, nonprescription safety glasses, a control box with signal converter and battery mount, cables from viewer to control box and from control box to signal source, a lithium-ion rechargeable battery and a battery charger. The LCD display unit is mounted on a pair of non-prescription safety glasses and is connected via a fourfoot cable to a small battery-powered control box that can be clipped onto a belt. A cable from the control box connects the control box to the video source. The battery is recharged using a separate battery charger. MicroOptical's Critical Data Viewers operate using a standard VGA signal and displaying it onto a small LCD.
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