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    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    PRIMUS

    K Number: K163195 · Decision Jun 21, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    30
    Same Product Code
    65
    Applicant Total
    2
    Review Days
    218

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    Basic Information

    Device Name
    PRIMUS
    K Number
    K163195
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1570
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Carl Zeiss Suzhou Co., Ltd.
    Date Received
    November 15, 2016
    Decision Date
    June 21, 2017
    Product Code
    OBO
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OBO Tomography, Optical Coherence

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