BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    OCT-Camera ID 21101A3

    K Number: K200516 · Decision Sep 2, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    30
    Same Product Code
    65
    Applicant Total
    2
    Review Days
    184

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    Basic Information

    Device Name
    OCT-Camera ID 21101A3
    K Number
    K200516
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1570
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Optomedical Technologies GmbH
    Date Received
    March 2, 2020
    Decision Date
    September 2, 2020
    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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