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

    Aegis Transit System

    K Number: K170757 · Decision Jul 14, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    10
    Applicant Total
    1
    Review Days
    123

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    Basic Information

    Device Name
    Aegis Transit System
    K Number
    K170757
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4720
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Boston-Biomedical Associates
    Date Received
    March 13, 2017
    Decision Date
    July 14, 2017
    Product Code
    EWY
    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
    EWY Mediastinoscope, Surgical

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