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

    THE ERGOSYSTEM CHAIR

    K Number: K863728 · Decision Oct 31, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    15
    Applicant Total
    1
    Review Days
    38

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    Basic Information

    Device Name
    THE ERGOSYSTEM CHAIR
    K Number
    K863728
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.1140
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Charles D. Bell, Inc.
    Date Received
    September 23, 1986
    Decision Date
    October 31, 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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