BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    HMB32 Dialysis Solution

    K Number: K212052 · Decision Jul 23, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    122
    Applicant Total
    2
    Review Days
    23

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    Basic Information

    Device Name
    HMB32 Dialysis Solution
    K Number
    K212052
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Haemopharm Biofluids S.R.L.
    Date Received
    June 30, 2021
    Decision Date
    July 23, 2021
    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 Haemopharm Biofluids S.R.L.

    K Number Device Name
    K150966 HMB32