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

    SOLCART B

    K Number: K102194 · Decision Apr 25, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    122
    Applicant Total
    5
    Review Days
    264

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    Basic Information

    Device Name
    SOLCART B
    K Number
    K102194
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    B. Braun Avitum AG
    Date Received
    August 4, 2010
    Decision Date
    April 25, 2011
    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 B. Braun Avitum AG

    K Number Device Name
    K170574 Diacap Pro Dialyzer
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    K100334 DIACAP POLYSULFONE HIFLO 23 HEMODILAYZER , MODEL 72036811
    K083460 DIALOG WITH ADIMEA OPTION