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510(k) Data Aggregation

    K Number
    K973318
    Device Name
    MOBIMED SYSTEM, (PEGASUS AND POLARIS)
    Manufacturer
    ORTIVUS US, INC.
    Date Cleared
    1998-02-19

    (168 days)

    Product Code
    MSX, 74D
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORTIVUS US, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ortivus AB Mobimed™ is a cardiac monitoring system consisting of a portable and stationary unit which communicate with each other using the Mobitex radio-based cellular telecommunications network. The cardiac data includes ECG, SpO2, NIBP, GCS, and patient information. The system is intended for use by trained personnel in emergency care, specifically emergency ambulance and pre-hospital care.
    Device Description
    The Mobimed™ System consists of one or several stationary units called Polaris (typically hospital located) receiving patient cardiac information from mobile units called Pegasus. A mobile unit can be permanently mounted in an ambulance or operate as a portable unit. The Mobimed™ equipment can telemonitor (using radiobased cellular telecommunications network) a patient where he or she is at the moment. This makes it possible to monitor the patient and acquire data during transportation to the hospital. The system can acquire and transmit the following information: VCG or 12-Lead ECG (automatically and manually acquired reports). One channel ECG or VCG reports. Monitoring ECG (not transmitted). Trends (automatically and manually acquired). Patient records/forms. Alarms (presented on the Pegasus and not transmitted to Polaris). Messages.
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