BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇮🇱 Israel

    Pulsenmore ES

    K Number: DEN240074 · Decision Oct 31, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    324

    Basic Information

    Device Name
    Pulsenmore ES
    K Number
    DEN240074
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    892.1590
    Medical Specialty
    Radiology
    Decision
    Unknown
    Applicant
    Pulsenmore, Ltd.
    Date Received
    December 11, 2024
    Decision Date
    October 31, 2025
    Product Code
    SGJ
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    SGJ Ultrasound Imaging System For Acquiring Images At Home By Lay Users