BEUDAMED
    Product Code: MMZ FDA class 2 21 CFR 876.4890

    Table, Cystometric, Electric

    Gastroenterology, Urology

    The Electric Cystometric Table is a motorized examination table used in urodynamics laboratories during cystometric evaluations to position patients appropriately and facilitate urodynamic testing procedures that assess bladder function, capacity, and compliance. Classified as a Class 2 device under 21 CFR 876.4890 within the Gastroenterology and Urology specialty, it requires 510(k) premarket notification. It carries no implant or life-sustaining flags.

    View on FDA
    510(k)s
    4
    FEI Numbers
    16
    Registration Numbers
    16
    Unique Applicants
    4
    Years Active
    9

    Basic Information

    Product Code
    MMZ
    Device Class
    FDA class 2
    Regulation Number
    876.4890
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    GU
    Submission Type
    4

    Device Characteristics

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

    510(k) Clearance History

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 4 510(k) clearances via K numbers.

    K Number Device Name
    K033335 LITHOSTAR MODULARIS WITH SHOCKWAVE SYSTEM CPLUS
    K954278 BETA MULTI-PROCEDURE MOBILE UROLOGICAL TABLE, MODEL S5005
    K942445 SYNERGY II
    K942485 MDT UROLOGY TABLE

    FEI Numbers

    This FDA classification entry is associated with 16 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 16 registration numbers. Click on an entry to view related FDA registrations.