BEUDAMED
    FDA Registration Active 🇺🇸 United States

    S7-2omni (21778A)

    Reg #: 2518586 · FEI: 2518586 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    24
    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
    K043535

    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

    S7-2omni (21778A) L12-3 S12-4 (21780A) D2cwc L15-7io S3-1 (21711A) S7-3t (21781A) 3D8-4 D5cwc L8-4 C8-5 C5-2 (21426A) L12-5 3D6-2 S8-3 (21750A) C8-4 (21437A) C9-5ec 3D9-3v PA4-2 (21422A) S4-2 T6H (21378A) HD11 Diagnostic Ultrasound System D2tcd C9-4

    Establishment Types

    Manufacture Medical Device