BEUDAMED
    Product Code: LRI FDA class 2 21 CFR 876.5820

    Ph Meter For Dialysis Hydrogen Ion Concentration

    Gastroenterology, Urology

    The pH Meter for Dialysis Hydrogen Ion Concentration is a device used to measure and monitor the pH of dialysis solutions, ensuring that the hydrogen ion concentration remains within safe therapeutic limits during hemodialysis or related renal replacement therapies. It is classified as a Class 2 (moderate risk) device, subject to general and special controls, and requires 510(k) premarket notification. The product code is LRI, regulated under 21 CFR 876.5820, within the Gastroenterology and Urology medical specialty. This device is designated as life-sustaining or life-supporting, reflecting its critical role in patient safety during dialysis.

    View on FDA
    510(k)s
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    LRI
    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 1 510(k) clearance via K numbers.

    K Number Device Name
    K870811 MODEL 102 PH METER