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    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES MODEL AS-851

    K Number: K982134 · Decision Apr 14, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    343
    Applicant Total
    4
    Review Days
    301

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    Basic Information

    Device Name
    DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES MODEL AS-851
    K Number
    K982134
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5860
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dynamic Technology Corp.
    Date Received
    June 17, 1998
    Decision Date
    April 14, 1999
    Product Code
    KDI
    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
    KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

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    Other Clearances by Dynamic Technology Corp.

    K Number Device Name
    K011537 DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES, MODEL: POLYSULFONE 100 HFS, POLYSULFONE 130 HFS
    K990159 DYNAMIC HOLLOW FIBER DIALYZER DH-SERIES, MODEL AH 90111
    K973291 DYNAMIC HOLLOW FIBER DIALYZER DC-SERIES