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510(k) Data Aggregation

    K Number
    K020534
    Device Name
    MEDSTAR SYSTEM, MODELS 533-300
    Manufacturer
    CYBERNET MEDICAL
    Date Cleared
    2003-02-11

    (357 days)

    Product Code
    DXH
    Regulation Number
    870.2920
    Why did this record match?
    Applicant Name (Manufacturer) :

    CYBERNET MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MedStar System is intended to transfer patient physiological data from a range of patient monitors to a remote station, such as a Disease Management Center, for subsequent transfer by a Hospital Information System for review by a healthcare professional. The MedStar System is intended for use with any patient requiring Out-of-Hospital monitoring. The MedStar System is not used directly with a patient. The MedStar Unit is intended for Out-of-Hospital Use. The associated Collection Server is intended for use in a Disease Management Center, Hospital or Hospital-Type facility, Medical Clinic or Physician's Office. The MedStar System is intended for sale by or on the order of a physician only. The MedStar System is indicated for Out-of-Hospital Use with any patient requiring Out-of-Hospital monitoring The associated Collection Server is intended for use in a Disease Management Center, Hospital or Hospital -Type facility, Medical Clinic or Physician's Office.
    Device Description
    The MedStar Monitoring System comprises the MedStar Unit and the associated Collection Server. The MedStar Unit is a portable, battery-operated unit for controlling the transmission of data from a range of compatible patient monitors or measurement devices to a remote monitoring center. Data is transmitted via telephone lines to the associated data collection server at the remote site. The MedStar Unit is contained in a small plastic enclosure with an LCD screen mounted into the top of the case. A User push button control is located adjacent to the display. Four serial communication ports are located at the side of the unit for connection to the serial data ports of specific patient monitors. Two standard phone jacks are also located at the side of the unit for connection to standard phone outlets. Two recessed programming buttons are included on the opposite side of the enclosure to the phone jacks. The Collection Server comprises a Personal Computer-type Processor Unit incorporating an additional electronics board to control phone line transmission to and from the MedStar Unit. The MedStar System accepts serial data from Blood/Glucose Monitors, Weight Scales, and NIBP Monitors. Monitored/measured data is transferred from a patient monitor/measurement device via that unit's serial data port under the control of a serial port protocol. The data is then stored in the MedStar Unit prior to undergoing Dual Tone Multiple Frequency, DTMF, encoding to facilitate phone line transmission to a remote site. A Collection Server receives and decodes the transmitted data and stores the data locally for subsequent transfer by a Hospital Information System for review by a healthcare professional. In addition to transferring encoded data from the three measurement devices described above, EKG data may also be transferred directly from an EKG Monitor to the Collection Server, via phone line, using an EKG Monitor's standard audio data output.
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