BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Ultrasound System 5500W

    Reg #: 3019216 · FEI: 3019216 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    Philips Ultrasound LLC
    Registration Number
    3019216
    FEI Number
    3019216
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    22100 Bothell Everett Hwy
    City
    BOTHELL
    State
    WA
    ZIP
    98021
    Country
    US

    Regulatory Submissions

    510(k) Number
    K242800

    Owner / Operator

    Firm Name
    Philips Medical Systems International BV
    Operator Number
    1217116
    Address
    Veenpluis 6
    City
    Best
    State
    NL-NOTA
    Postal Code
    5684PC
    Country
    NL

    Products

    Device Name Product Code
    Automated Radiological Image Processing Software QIH
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Echo, Ultrasonic IYO

    Proprietary Names

    Ultrasound System 5500W Ultrasound System 5300G Ultrasound System 5500P Ultrasound System 5500G Ultrasound System Ultrasound System 5300W Ultrasound System 5500CV Ultrasound System 5300P

    Establishment Types

    Manufacture Medical Device