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

    SARTORIUS AQUASART SM 40035 - DIALYSATE SYS

    K Number: K850435 · Decision Jun 4, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    11
    Applicant Total
    8
    Review Days
    120

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    SARTORIUS AQUASART SM 40035 - DIALYSATE SYS
    K Number
    K850435
    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
    February 4, 1985
    Decision Date
    June 4, 1985
    Product Code
    FKR
    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
    FKR Subsystem, Proportioning

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (FKR), ordered by most recent decision date.

    NXSTAGE PUREFLOW SL

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    NXSTAGE PUREFLOW SL

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    NXSTAGE PUREFLOW SL

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    NXSTAGE DIALYSATE PREPARATION MODULE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    AUTO-D AUTOMATIC DISINFECTION ACCESS/ATTACHMENTS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    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
    K844504 SARTORIUS MINISART SM 16596HY
    K830487 HEMO-PROCESSING SYSTEM
    K823132 SARTOPHOR SYSTEM FOR ELECTROPHORESIS
    K822285 CELLULOSE ACETATE MEMBRANE STRIPS