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

    IRAS EDS INTERFEROMETRIC STIMULATOR

    K Number: K873990 · Decision Feb 5, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    17
    Applicant Total
    6
    Review Days
    127

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    Basic Information

    Device Name
    IRAS EDS INTERFEROMETRIC STIMULATOR
    K Number
    K873990
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1630
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Randwal Instrument Co., Inc.
    Date Received
    October 1, 1987
    Decision Date
    February 5, 1988
    Product Code
    HLX
    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
    HLX Photostimulator, Ac-Powered

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