BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇺🇸 United States

    iotaSOFT Insertion System - Drive Unit, Controller and Accessories

    K Number: DEN190055 · Decision Oct 1, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    653

    Basic Information

    Device Name
    iotaSOFT Insertion System - Drive Unit, Controller and Accessories
    K Number
    DEN190055
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    874.4450
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Unknown
    Applicant
    IotaMotion, Inc.
    Date Received
    December 18, 2019
    Decision Date
    October 1, 2021
    Product Code
    QQH
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QQH Powered Insertion System For A Cochlear Implant Electrode Array