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

    Isopure Dry Acid Dissolution System

    K Number: K191093 · Decision Jan 22, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    122
    Applicant Total
    5
    Review Days
    272

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    Basic Information

    Device Name
    Isopure Dry Acid Dissolution System
    K Number
    K191093
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Isopure, Corp.
    Date Received
    April 25, 2019
    Decision Date
    January 22, 2020
    Product Code
    KPO
    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
    KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)

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    Other Clearances by Isopure, Corp.

    K Number Device Name
    K120005 ACDS
    K112427 BICARB MIXING AND DISTRIBUTION SYSTEM
    K041163 ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 600 SERIES
    K993200 MD 420/440/460/470/480/490