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510(k) Data Aggregation

    K Number
    K220530
    Device Name
    Tetragraph Neuromuscular Transmission Monitor
    Manufacturer
    Senzime AB
    Date Cleared
    2022-08-17

    (174 days)

    Product Code
    KOI
    Regulation Number
    868.2775
    Why did this record match?
    Applicant Name (Manufacturer) :

    Senzime AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TetraGraph Neuromuscular Transmission (NMT) Monitor is indicated for monitoring the relaxation of the patient when neuromuscular blockade is administered.
    Device Description
    The TetraGraph Neuromuscular Transmission (NMT) Monitor (TetraGraph) is a portable, batteryoperated EMG-based neuromuscular transmission monitor for use perioperative and in recovery and critical care environments following or during the application of Neuromuscular block. TetraGraph undertakes this function by electrical stimulation of the peripheral nerve and directly measuring the evoked response of the muscles (Muscle Action Potential (MAP)), thus providing a quantitative and automatic measurement of muscle response to a stimulus using electromyography (EMG). The TetraGraph is a prescription-only medical device and is indicated for use in hospitals. TetraGraph consists of the following main components: TetraGraph Monitor, TetraSens Electrode, TetraSens Pediatric Electrode (new accessory), Philips Interface (new and optional accessory), and Pole clamp kit (optional accessory).
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    K Number
    K190795
    Device Name
    Tetragraph Neuromuscular Transmission Monitor
    Manufacturer
    Senzime AB
    Date Cleared
    2019-10-18

    (204 days)

    Product Code
    KOI
    Regulation Number
    868.2775
    Why did this record match?
    Applicant Name (Manufacturer) :

    Senzime AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TetraGraph Neuromuscular Transmission (NMT) Monitor is indicated for monitoring the relaxation of the patient when neuromuscular blockade is administered.
    Device Description
    The TetraGraph Neuromuscular Transmission (NMT) Monitor (TetraGraph) is a portable, battery-operated EMG-based neuromuscular transmission monitor for use perioperative and in recovery and critical care environments following or during the application of Neuromuscular block. TetraGraph undertakes this function by electrical stimulation of the peripheral nerve and directly measuring the evoked response of the muscles (Muscle Action Potential (MAP)), thus providing a quantitative and automatic measurement of muscle response to a stimulus using electromyography (EMG).
    Ask a Question

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