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

    RETINOMETER

    K Number: K781507 · Decision Nov 15, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    4
    Applicant Total
    14
    Review Days
    75

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    Basic Information

    Device Name
    RETINOMETER
    K Number
    K781507
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1360
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Coburn Optical Ind., Inc.
    Date Received
    September 1, 1978
    Decision Date
    November 15, 1978
    Product Code
    HPJ
    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
    HPJ Instrument, Visual Field, Laser

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    Other Clearances by Coburn Optical Ind., Inc.

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    K892348 MAGNILINK SYSTEM 201
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