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

    HPF 100,200,300 CAPILLARY FLOW DIALYZ

    K Number: K822485 · Decision Aug 30, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    60
    Applicant Total
    43
    Review Days
    13

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    Basic Information

    Device Name
    HPF 100,200,300 CAPILLARY FLOW DIALYZ
    K Number
    K822485
    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 17, 1982
    Decision Date
    August 30, 1982
    Product Code
    FKQ
    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
    FKQ System, Dialysate Delivery, Central Multiple Patient

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