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510(k) Data Aggregation

    K Number
    K172843
    Device Name
    TwitchView System
    Manufacturer
    Blink Device Corporation
    Date Cleared
    2018-03-29

    (191 days)

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

    Blink Device Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The TwitchView System is used for the quantitative monitoring of neuromuscular transmission by means of electromyography.
    Device Description
    The TwitchView System has been designed to provide a quantitative neuromuscular transmission monitor with a modernized user interface and a single-use electrode array that is placed on the hand of the patient. The degree of neuromuscular block is measured with the TwitchView System by stimulating a peripheral nerve (the ulnar nerve at the wrist), and by evaluating the response of the hand via electromyography. The TwitchView System consists of three components: 1. TwitchView Monitor, 2. TwitchView Charging Station, 3. Single-Use Electrode Array.
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