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

    RetCam 3 ; RetCam Shuttle ; RetCam Portable

    K Number: K182263 · Decision Sep 7, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    66
    Same Product Code
    155
    Applicant Total
    10
    Review Days
    17

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    Basic Information

    Device Name
    RetCam 3 ; RetCam Shuttle ; RetCam Portable
    K Number
    K182263
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    886.1120
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Natus Medical Incorporated
    Date Received
    August 21, 2018
    Decision Date
    September 7, 2018
    Product Code
    HKI
    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
    HKI Camera, Ophthalmic, Ac-Powered

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