BEUDAMED
    FDA Registration Active 🇺🇸 United States

    L12-4

    Reg #: 3017894900 · FEI: 3017894900 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Philips Ultrasound LLC
    Registration Number
    3017894900
    FEI Number
    3017894900
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    222 Jacobs Street
    City
    Cambridge
    State
    MA
    ZIP
    02141
    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

    Develop Specifications But Do Not Manufacture At This Facility