BEUDAMED
    FDA Registration Active 🇺🇸 United States

    L12-5 50

    Reg #: 2518586 · FEI: 2518586 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    32
    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
    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