BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    CLIRANS TE08 HOLLOW FIBER DIALYZER

    K Number: K823768 · Decision Jan 8, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    9
    Applicant Total
    143
    Review Days
    25

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    Basic Information

    Device Name
    CLIRANS TE08 HOLLOW FIBER DIALYZER
    K Number
    K823768
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4170
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Terumo Medical Corp.
    Date Received
    December 14, 1982
    Decision Date
    January 8, 1983
    Product Code
    HRN
    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
    HRN Unit, Cryophthalmic, Ac-Powered

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