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

    PENTAX EPK-I5010 VIDEO PROCESSOR

    K Number: K122470 · Decision Apr 10, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    8
    Applicant Total
    6
    Review Days
    240

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    Basic Information

    Device Name
    PENTAX EPK-I5010 VIDEO PROCESSOR
    K Number
    K122470
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pentax Medical
    Date Received
    August 13, 2012
    Decision Date
    April 10, 2013
    Product Code
    PEA
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    PEA Endoscope, Accessories, Image Post-Processing For Color Enhancement

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    Other Clearances by Pentax Medical

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