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

    RELIANCE 1000, RELIANCE 1500, RELIANCE 2000

    K Number: K853149 · Decision Sep 5, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    15
    Applicant Total
    9
    Review Days
    38

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    Basic Information

    Device Name
    RELIANCE 1000, RELIANCE 1500, RELIANCE 2000
    K Number
    K853149
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.1140
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    F. & F. Koenigkramer
    Date Received
    July 29, 1985
    Decision Date
    September 5, 1985
    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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