BEUDAMED
    Product Code: MON FDA class 1 21 CFR 876.5820

    System, Hemodialysis, Remote Accessories

    Gastroenterology, Urology

    The Hemodialysis System Remote Accessories are supplementary components used with hemodialysis systems to support remote monitoring, connectivity, or ancillary functions of the dialysis process. Classified as FDA Class 1 under 21 CFR 876.5820 in the Gastroenterology and Urology specialty, these accessories are 510(k)-exempt and subject only to general controls. The product code is MON.

    View on FDA
    510(k)s
    0
    FEI Numbers
    17
    Registration Numbers
    17
    Unique Applicants
    0
    Years Active
    —

    Research product code MON in seconds

    The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Product Code
    MON
    Device Class
    FDA class 1
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    GU
    Submission Type
    4

    Device Characteristics

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

    FEI Numbers

    This FDA classification entry is associated with 17 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 17 registration numbers. Click on an entry to view related FDA registrations.