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

    SARTORIUS MINISART SM 16596HY

    K Number: K844504 · Decision Jan 18, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    181
    Applicant Total
    8
    Review Days
    59

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    Basic Information

    Device Name
    SARTORIUS MINISART SM 16596HY
    K Number
    K844504
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Sartorius Filters, Inc.
    Date Received
    November 20, 1984
    Decision Date
    January 18, 1985
    Product Code
    KOC
    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
    KOC Accessories, Blood Circuit, Hemodialysis

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    Other Clearances by Sartorius Filters, Inc.

    K Number Device Name
    K851818 SARTORIUS MINI SART FH 16592
    K851817 SARTORIUS MINI-SART FH 16555
    K851816 SARTORIUS MINISART FH 16534
    K850435 SARTORIUS AQUASART SM 40035 - DIALYSATE SYS
    K830487 HEMO-PROCESSING SYSTEM
    K823132 SARTOPHOR SYSTEM FOR ELECTROPHORESIS
    K822285 CELLULOSE ACETATE MEMBRANE STRIPS