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510(k) Data Aggregation

    K Number
    K182297
    Device Name
    Surveyor S2
    Date Cleared
    2019-01-24

    (153 days)

    Product Code
    Regulation Number
    870.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    Mortara Instrument Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Surveyor S2 is indicated for use: · The Surveyor S2 is indicated for use in adult, adolescents, and children patient populations. The Surveyor S2 facilitates the monitoring of ECG signals. · The Surveyor S2 is a prescription device intended to be used by knowledgeable healthcare professionals within a healthcare facility or clinical pharmacology unit. · The Surveyor S2 is indicated for use in a clinical setting by a physician, or by trained personnel acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis. · The Surveyor S2 is indicated for use to acquire and output electrocardiographic data. · The Surveyor S2 is indicated for use as a radiofrequency physiological signal transceiver, receiving and delivering realtime acquisition and transmission of simultaneous electrocardiographic data, while allowing the patient to be ambulatory within the range of the antenna network.
    Device Description
    The Surveyor S2 is a patient-worn, battery-powered telemetry transmitter. The Surveyor S2 is intended to acquire ECG signals and transmits waveforms and corresponding status to a receiving S2 Communication Library. The S2 Communication Library, to be integrated in an external monitoring node for processing, exposes an API to obtain ECG signals and push session status, parameters and demographic information to the S2. The ECG acquired signals are transmitted through the S2 communication Library to the Monitoring Node for further processing, presentation, storage, etc via the hospital/clinic wireless and wired network infrastructure. The Surveyor S2 is designed to be used within the existing network IT infrastructure. The Surveyor S2 has a 2.8'' color display with a capacitive touch sensitive screen, allowing for operational conveniences such as a battery level indicator, Wi-Fi Signal Strength and on-demand visual indication of the status of its connection to the monitoring node. The Surveyor S2 acquires and sends signals to the monitoring node where ECG signal processing and monitoring occurs. The Surveyor S2 displays ECG derived parameters (Heart Rate) and demographic data and monitoring state as received from the monitoring node through the S2 Communication Library. The Surveyor S2 provides continuous data acquisition which can be visualized on the S2 itself for the ECG waveforms. The Surveyor S2 utilizes ECG lead cables available in AHA or IEC, snap or clip, 4-wire Lead. ECG data delivered is 3-leads, lossless compressed, 2.5 µV LSB at 500 samples per second. ECG data is augmented with electrode fail markers, lead identifications, hardware detected pacemaker spikes.
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