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

    Voyant System

    K Number: K181885 · Decision Oct 2, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    368
    Registration Numbers
    368
    Same Product Code
    669
    Applicant Total
    2
    Review Days
    81

    Basic Information

    Device Name
    Voyant System
    K Number
    K181885
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.1100
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Viseon, Inc.
    Date Received
    July 13, 2018
    Decision Date
    October 2, 2018
    Product Code
    HRX
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HRX Arthroscope

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    Other Clearances by Viseon, Inc.

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