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510(k) Data Aggregation

    K Number
    K212434
    Device Name
    Neuromuscular Transmission Monitor TOF3D
    Manufacturer
    MIPM Mammendorfer Institut für Physik und Medizin GmbH
    Date Cleared
    2022-05-05

    (274 days)

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

    MIPM Mammendorfer Institut für Physik und Medizin GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TOF3D is used to objectively monitor the level of neuromuscular transmission by measuring muscle contraction following stimulation. The TOF3D can also be used as a peripheral nerve stimulator (without the objective measuring function) for subjective monitoring. The device is intended for use for adolescents greater than 18 through 21 years of age, and adults.
    Device Description
    The Neuromuscular Transmission Monitor TOF3D is capable to monitor the level of neuromuscular transmission (NMT) during surgery of in the intensive care unit by stimulating different nerves and measuring the response of the respective muscles to the stimulation. The different locations for monitoring are for instance the ulnar nerve/adductor pollicis muscle, the posterior tibial nerve/flexor halluces brevis muscle and the facial nerve/orbicularis oculi muscle. The Neuromuscular Transmission Monitor TOF3D uses acceleromyography (AMG) measurement for recording of evoked muscle responses. The results are shown on the LCD display of the device and shall aid qualified medical staff to maintain the proper level of neuromuscular block and to determine the level of recovery from neuromuscular block.
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