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

    RELIANCE 5000

    K Number: K853151 · 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 5000
    K Number
    K853151
    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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    Other Clearances by F. & F. Koenigkramer

    K Number Device Name
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    K853150 RELIANCE 6100
    K843046 RELIANCE TREATMENT CABINET
    K834060 RELIANCE OPHTHALMIC SLIT LAMP R-083
    K831568 RELIANCE TEMPO OPHTH. INSTR STAND
    K812544 RELIANCE OPHTHALMIC INSTRUMENT CONTROL
    K761147 RELIANCE MOD-U-LINE M-700