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

    AMER. EDWARDS LAB FLEXISCOPE

    K Number: K842410 · Decision Nov 5, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    1
    Applicant Total
    89
    Review Days
    139

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    Basic Information

    Device Name
    AMER. EDWARDS LAB FLEXISCOPE
    K Number
    K842410
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4855
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    American Edwards Laboratories
    Date Received
    June 19, 1984
    Decision Date
    November 5, 1984
    Product Code
    HRK
    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
    HRK Table, Instrument, Manual, Ophthalmic

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