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

    NATURALYTE BICARBONATE CONCENTRATE-DRY PACK

    K Number: K852310 · Decision Jul 26, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    60
    Applicant Total
    43
    Review Days
    58

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    Basic Information

    Device Name
    NATURALYTE BICARBONATE CONCENTRATE-DRY PACK
    K Number
    K852310
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Erika, Inc.
    Date Received
    May 29, 1985
    Decision Date
    July 26, 1985
    Product Code
    FKQ
    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
    FKQ System, Dialysate Delivery, Central Multiple Patient

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    Other Clearances by Erika, Inc.

    K Number Device Name
    K853134 NATIONAL MED CARE INFUSION PUMP ADM SET #95-0001-8
    K852309 ERIKA ART LI, 3-9621-8, 22-6, 23-4 & VEN 9714-1
    K850865 TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1-
    K850866 TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1L
    K850655 TORAY IND. FILTRYZER HOLLOW FIBER ARTIF. KIDNEY B2
    K850654 TORAY INDUS. FILTRYZER HOLLOW FIBER ARTIFICIAL KID
    K842436 ERIKA NEGATIVE PRESS. ARTERIAL BLOOD
    K831175 FILTRYZER HOLLOW FIBER ARTIF. KIDNEY
    K831173 TORAY INDUSTRIES FILTRYZER HOLLOW FIBER
    K831176 FILTRYZER HOLLOW FIBER ARTIF. KIDNEY
    Search all 43 clearances from Erika, Inc. →