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

    DIALYZER (MODEL 1850)

    K Number: K760374 · Decision Oct 27, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    11
    Applicant Total
    43
    Review Days
    83

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    Basic Information

    Device Name
    DIALYZER (MODEL 1850)
    K Number
    K760374
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Erika, Inc.
    Date Received
    August 5, 1976
    Decision Date
    October 27, 1976
    Product Code
    FHS
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FHS Dialyzer, Single Coil

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