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

    MODEL 6500 OPTHALMIC CHAIR

    K Number: K864494 · Decision Dec 15, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    15
    Applicant Total
    5
    Review Days
    31

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    Basic Information

    Device Name
    MODEL 6500 OPTHALMIC CHAIR
    K Number
    K864494
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.1140
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Koken Mfg Company, Inc.
    Date Received
    November 14, 1986
    Decision Date
    December 15, 1986
    Product Code
    HME
    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
    HME Chair, Ophthalmic, Ac-Powered

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