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

    O.2 MICRON INFECTION RESISTANT HYDROPHOBIC FILTER

    K Number: K862015 · Decision Jul 22, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    34
    Applicant Total
    10
    Review Days
    55

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    Basic Information

    Device Name
    O.2 MICRON INFECTION RESISTANT HYDROPHOBIC FILTER
    K Number
    K862015
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Bipore, Inc.
    Date Received
    May 28, 1986
    Decision Date
    July 22, 1986
    Product Code
    FIB
    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
    FIB Protector, Transducer, Dialysis

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