BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    CRYSTALEYE SPECTROPHOTOMETER/CRYSTALEYE BASIC SET, MODEL CE100-DC/US

    K Number: K072643 · Decision Nov 16, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    1
    Applicant Total
    5
    Review Days
    59

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    Basic Information

    Device Name
    CRYSTALEYE SPECTROPHOTOMETER/CRYSTALEYE BASIC SET, MODEL CE100-DC/US
    K Number
    K072643
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3661
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Olympus Corporation
    Date Received
    September 18, 2007
    Decision Date
    November 16, 2007
    Product Code
    KZN
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KZN Scanner, Color

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