BEUDAMED
    FDA Registration Active 🇺🇸 United States

    12S-RS

    Reg #: 3002183074 · FEI: 3002183074 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    16
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    GE Medical Systems Ultrasound & Primary Care Diagnostics LLC
    Registration Number
    3002183074
    FEI Number
    3002183074
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    14470 Bergen Blvd.
    City
    Noblesville
    State
    IN
    ZIP
    46060
    Country
    US

    Regulatory Submissions

    510(k) Number
    K220848

    Owner / Operator

    Firm Name
    GE HealthCare Technologies Inc.
    Operator Number
    9912004
    Address
    3000 N. Grandview Blvd
    City
    Waukesha
    State
    WI
    Postal Code
    53188
    Country
    US

    Products

    Device Name Product Code
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Transducer, Ultrasonic, Diagnostic ITX

    Proprietary Names

    12S-RS ML6-15-RS C1-5-RS 6Tc-RS 8C-RS L10-22-RS L8-18i-RS 6S-RS 3Sc-RS L4-20t-RS Venue Fit E8C-RS L4-12t-RS 12L-RS 9L-RS M5Sc-RS

    Establishment Types

    Remanufacture Medical Device