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

    BICARB MIXING AND DISTRIBUTION SYSTEM

    K Number: K112427 · Decision Jan 26, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    17
    Applicant Total
    5
    Review Days
    156

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    Basic Information

    Device Name
    BICARB MIXING AND DISTRIBUTION SYSTEM
    K Number
    K112427
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Isopure, Corp.
    Date Received
    August 23, 2011
    Decision Date
    January 26, 2012
    Product Code
    FIN
    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
    FIN Tank, Holding, Dialysis

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    Other Clearances by Isopure, Corp.

    K Number Device Name
    K191093 Isopure Dry Acid Dissolution System
    K120005 ACDS
    K041163 ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 600 SERIES
    K993200 MD 420/440/460/470/480/490