BEUDAMED
    Product Code: FIK FDA class 2 21 CFR 876.5820

    System, Dialysate Delivery, Recirculating

    Gastroenterology, Urology

    The Recirculating Dialysate Delivery System is a hemodialysis device that recirculates and regenerates dialysate during treatment, reducing the volume of dialysate required per session. It is classified as FDA Class 2, requiring 510(k) premarket clearance, and is considered life-sustaining or life-supporting. The product code is FIK, regulated under 21 CFR 876.5820, within the Gastroenterology, Urology specialty.

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    510(k)s
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    FIK
    Device Class
    FDA class 2
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    GU
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✓
    Life Sustain/Support
    ✗
    Third Party
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    Summary Malfunction Reporting