BEUDAMED
    Product Code: FJB FDA class 2 21 CFR 876.5820

    Detector, Dialysate Level

    Gastroenterology, Urology

    The Dialysate Level Detector is a sensor component of a hemodialysis system that monitors the volume or level of dialysate in a reservoir or delivery system to prevent underfilling or overflow during treatment. It is classified as FDA Class 2, requiring 510(k) premarket clearance, and is considered life-sustaining or life-supporting. The product code is FJB, regulated under 21 CFR 876.5820, within the Gastroenterology, Urology specialty.

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    510(k)s
    3
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    3
    Years Active
    1

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    Basic Information

    Product Code
    FJB
    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
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 3 510(k) clearances via K numbers.

    K Number Device Name
    K883490 ACCUFLO UF CONTROL MODULE NO. 74-0100-3
    K881062 CENTRY 2 ULTRAFILTRATION CONTROL KIT, #018762-002
    K875312 UFR DIGITAL RETROFIT