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

    KOI BLUE FIELD ENTOPTOSCOPE

    K Number: K812764 · Decision Dec 2, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    5
    Applicant Total
    7
    Review Days
    61

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    Basic Information

    Device Name
    KOI BLUE FIELD ENTOPTOSCOPE
    K Number
    K812764
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1780
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Koi, Inc.
    Date Received
    October 2, 1981
    Decision Date
    December 2, 1981
    Product Code
    HKL
    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
    HKL Retinoscope, Ac-Powered

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