BEUDAMED
    FDA Registration Active 🇺🇸 United States

    L12-4

    Reg #: 2518586 · FEI: 2518586 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Philips Ultrasound LLC
    Registration Number
    2518586
    FEI Number
    2518586
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1 Echo Dr
    City
    Reedsville
    State
    PA
    ZIP
    17084
    Country
    US

    Regulatory Submissions

    510(k) Number
    K120321

    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
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Echo, Ultrasonic IYO

    Proprietary Names

    L12-4 ClearVue 350 Diagnostic Ultrasound System S4-1 C9-4v 3D9-3v C5-2 ClearVue 650 Diagnostic Ultrasound System ClearVue 550 Diagnostic Ultrasound System V6-2 ClearVue 580 Diagnostic Ultrasound System

    Establishment Types

    Manufacture Medical Device