BEUDAMED
    FDA Registration Active 🇺🇸 United States

    LAP L9-5

    Reg #: 2518586 · FEI: 2518586 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    21
    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
    K123754

    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

    LAP L9-5 X7-2t C10-3v L12-4 S4-2 C9-3v C6-2 CX50 Diagnostic Ultrasound System CX30 Diagnostic Ultrasound System D2cwc S5-1 C9-4v C9-3io L15-7io S8-3 D5cwc L12-3 C8-5 S12-4 L12-5 50 C5-1

    Establishment Types

    Manufacture Medical Device