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

    OCT-Camera

    K Number: K142953 · Decision Mar 4, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    86
    Applicant Total
    2
    Review Days
    145

    Basic Information

    Device Name
    OCT-Camera
    K Number
    K142953
    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
    October 10, 2014
    Decision Date
    March 4, 2015
    Product Code
    HLI
    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
    HLI Ophthalmoscope, Ac-Powered

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