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

    Monarch Endoscopy Platform (Monarch Platform)

    K Number: K173760 · Decision Mar 22, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    163
    Registration Numbers
    163
    Same Product Code
    238
    Applicant Total
    2
    Review Days
    101

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    Basic Information

    Device Name
    Monarch Endoscopy Platform (Monarch Platform)
    K Number
    K173760
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4680
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Auris Surgical Robotics, Inc.
    Date Received
    December 11, 2017
    Decision Date
    March 22, 2018
    Product Code
    EOQ
    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
    EOQ Bronchoscope (Flexible Or Rigid)

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    Other Clearances by Auris Surgical Robotics, Inc.

    K Number Device Name
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