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

    ULTRASIGHTHD C31 WITH IMAGESENSE AND REMOTE VIEWER TELEMEDICINE

    K Number: K110147 · Decision Apr 8, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    55
    Applicant Total
    2
    Review Days
    80

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    Basic Information

    Device Name
    ULTRASIGHTHD C31 WITH IMAGESENSE AND REMOTE VIEWER TELEMEDICINE
    K Number
    K110147
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1630
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sti Medical Systems, LLC
    Date Received
    January 18, 2011
    Decision Date
    April 8, 2011
    Product Code
    HEX
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HEX Colposcope (And Colpomicroscope)

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