BEUDAMED
    FDA Registration Active 🇺🇸 United States

    L12-5 50

    Reg #: 3019216 · FEI: 3019216 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    32
    Establishment Types
    1
    Classifications
    3

    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
    K132304

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

    Proprietary Names

    L12-5 50 Affiniti 70 Diagnostic Ultrasound System S5-1 C10-3v C6-2 VL13-5 S8-3 EPIQ 5 Diagnostic Ultrasound System C5-1 C9-4v C8-5 D5cwc L12-4 C10-4ec X6-1 Affiniti 50 Diagnostic Ultrasound System BP10-5ec V6-2 S12-4 C9-2 D2tcd X5-1 S4-2 S7-3t X7-2 L18-5 L15-7io EPIQ 7 Diagnostic Ultrasound System 3D9-3v D2cwc L12-3 X7-2t

    Establishment Types

    Manufacture Medical Device