BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    DIOPTRON III AUTOREFRACTOR

    K Number: K801906 · Decision Aug 27, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    75
    Same Product Code
    34
    Applicant Total
    6
    Review Days
    16

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    Basic Information

    Device Name
    DIOPTRON III AUTOREFRACTOR
    K Number
    K801906
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.1760
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Coherent Medical Division
    Date Received
    August 11, 1980
    Decision Date
    August 27, 1980
    Product Code
    HKO
    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
    HKO Refractometer, Ophthalmic

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