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    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    UNIMAX ANTI-FOG SOLUTION

    K Number: K111622 · Decision Sep 9, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    26
    Applicant Total
    7
    Review Days
    91

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    Basic Information

    Device Name
    UNIMAX ANTI-FOG SOLUTION
    K Number
    K111622
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Unimax Medical Systems, Inc.
    Date Received
    June 10, 2011
    Decision Date
    September 9, 2011
    Product Code
    OCT
    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
    OCT Anti Fog Solution And Accessories, Endoscopy

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