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

    HF-100 DIALYZER

    K Number: K802092 · Decision Dec 18, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    130
    Applicant Total
    5
    Review Days
    107

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    Basic Information

    Device Name
    HF-100 DIALYZER
    K Number
    K802092
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Bio-Med Corp.
    Date Received
    September 2, 1980
    Decision Date
    December 18, 1980
    Product Code
    FJI
    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
    FJI Dialyzer, Capillary, Hollow Fiber

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    Other Clearances by Bio-Med Corp.

    K Number Device Name
    K823286 MODELS DPT 1000/DPT 1000NS
    K810735 DISPOSABLE, STERILE TRANSDUCER DOMES
    K801985 BIO-MED CORP. DISP. NON-STERILE TRANSDU
    K802069 DISP. TRANSDUCER DOMES TD200 & TD300