BEUDAMED
    Product Code: FIW FDA class 2 21 CFR 876.5820

    Alarm, Pillow Pressure

    Gastroenterology, Urology

    The Pillow Pressure Alarm is a monitoring device used in hemodialysis to detect and alert to pressure changes in the blood circuit, providing a safety mechanism to protect the patient 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 FIW, regulated under 21 CFR 876.5820, within the Gastroenterology, Urology specialty.

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

    Basic Information

    Product Code
    FIW
    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
    K772355 BLOOD LINE COMP. NEG. PRESS. PILLOW