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    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    Neuromuscular Transmission Monitor TOF3D

    K Number: K212434 · Decision May 5, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    28
    Applicant Total
    2
    Review Days
    274

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    Basic Information

    Device Name
    Neuromuscular Transmission Monitor TOF3D
    K Number
    K212434
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2775
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    MIPM Mammendorfer Institut für Physik und Medizin GmbH
    Date Received
    August 4, 2021
    Decision Date
    May 5, 2022
    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 MIPM Mammendorfer Institut für Physik und Medizin GmbH

    K Number Device Name
    K250887 Neuromuscular Transmission Monitor TOF3D (2510091)