BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇺🇸 United States

    THE 3PM EGG MACHINE

    K Number: DEN990005 · Decision Aug 20, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    7
    Applicant Total
    1
    Review Days
    39

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    THE 3PM EGG MACHINE
    K Number
    DEN990005
    Device Class
    FDA class 2
    Clearance Type
    Post-NSE
    Regulation Number
    876.1735
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Applicant
    3pm Co., Inc.
    Date Received
    July 12, 1999
    Decision Date
    August 20, 1999
    Product Code
    MYE
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MYE System, Electrogastrography (Egg)

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (MYE), ordered by most recent decision date.

    Gastric Alimetry

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Gastric Alimetry

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Gastric Alimetry System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Gastric Alimetry System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Gastric Alimetry System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    G-Tech Wireless Patch System (WPS)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all