BEUDAMED
    FDA Registration Active 🇺🇸 United States

    C9-5ec

    Reg #: 2518586 · FEI: 2518586 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    37
    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
    K030455

    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

    C9-5ec T6H X5-1 C10-3v X7-2t S8-3t L9-5 LAP C8-4v D2 TC L9-3 C5-2 S12-4 D2tcd L12-5 50mm S8-3 3D9-3v iU22 Diagnostic Ultrasound System C9-4 VL13-5 L11-3 iE33 Diagnostic Ultrasound System S7-3t D5cwc D2 CW D2cwc S3-1 L15-7io V6-2 X6-1 L8-4 L17-5 X7-2 S7-2omni T6207 C8-5 S4-1 L12-5 38mm

    Establishment Types

    Manufacture Medical Device