BEUDAMED
    FDA Registration Active 🇺🇸 United States

    S4-2

    Reg #: 2518586 · FEI: 2518586 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    26
    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
    K162329

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

    Proprietary Names

    S4-2 L10-4lap L12-4 D2cwc C9-3v X7-2t C9-4v S7-3t S8-3 CX50 Diagnostic Ultrasound System L12-3 C10-3v Sparq Diagnostic Ultrasound System C8-5 L12-5 50 L15-7io S12-4 C9-3io C6-2 S5-1 C5-1 D5cwc Sparq Circular Edition Diagnostic Ultrasound System CX50 Circular Edition Diagnostic Ultrasound System CX50 Diamond Select Diagnostic Ultrasound System Sparq Diamond Select Diagnostic Ultrasound System

    Establishment Types

    Manufacture Medical Device