BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇪 Sweden

    Tetragraph Neuromuscular Transmission Monitor

    K Number: K190795 · Decision Oct 18, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    28
    Applicant Total
    3
    Review Days
    204

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    Basic Information

    Device Name
    Tetragraph Neuromuscular Transmission Monitor
    K Number
    K190795
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2775
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Senzime AB
    Date Received
    March 28, 2019
    Decision Date
    October 18, 2019
    Product Code
    KOI
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KOI Stimulator, Nerve, Peripheral, Electric

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    Other Clearances by Senzime AB

    K Number Device Name
    K261098 TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017)
    K220530 Tetragraph Neuromuscular Transmission Monitor