BEUDAMED
    Product Code: MYE FDA class 2 21 CFR 876.1735

    System, Electrogastrography (Egg)

    Gastroenterology, Urology

    The Electrogastrography (EGG) System is a diagnostic device that records the electrical activity of the stomach through electrodes placed on the skin of the abdomen, analogous to an electrocardiogram for the heart. It is used to evaluate gastric motility disorders such as gastroparesis, nausea, and vomiting. Classified as FDA Class 2, it requires 510(k) premarket clearance under regulation 876.1735 (Gastroenterology and Urology specialty).

    View on FDA
    510(k)s
    8
    FEI Numbers
    3
    Registration Numbers
    3
    Unique Applicants
    4
    Years Active
    26

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    Basic Information

    Product Code
    MYE
    Device Class
    FDA class 2
    Regulation Number
    876.1735
    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 8 510(k) clearances via K numbers.

    K Number Device Name
    K252504 Gastric Alimetry
    K240946 Gastric Alimetry
    K232925 Gastric Alimetry System
    K223398 Gastric Alimetry System
    K213924 Gastric Alimetry System
    K212954 G-Tech Wireless Patch System (WPS)
    K014269 POLYGRAM NET ELECTROGASTROGRAPHY APPLICATION SOFTWARE, MODEL 9043S0151; POLYGRAF ID, MODEL 9043G0102
    DEN990005 THE 3PM EGG MACHINE

    FEI Numbers

    This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.