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

    IRAS PERIMETER

    K Number: K864012 · Decision Dec 12, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    4
    Applicant Total
    6
    Review Days
    58

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    Basic Information

    Device Name
    IRAS PERIMETER
    K Number
    K864012
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1360
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Randwal Instrument Co., Inc.
    Date Received
    October 15, 1986
    Decision Date
    December 12, 1986
    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 Randwal Instrument Co., Inc.

    K Number Device Name
    K873990 IRAS EDS INTERFEROMETRIC STIMULATOR
    K873987 IRAS GLARE TESTER
    K853556 LASER IRAS
    K842567 PORTABLE ACUIOMETER
    K827577 VARIABLE CONTRAST ACUIOMETER, DIAGNOSTIC LASER INTERFEROMETER