BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    C9-4v

    Reg #: 3000126629 · FEI: 3000126629 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    46
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Philips Electronics Ltd
    Registration Number
    3000126629
    FEI Number
    3000126629
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1875 Buckhorn Gate, 5th Floor
    City
    Mississauga Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K163120

    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

    US Agent

    Business Name
    Philips
    Contact Name
    Shaylee Masilunas
    Address
    6501 Living Place
    City
    Pittsburgh
    State
    PA
    ZIP
    15206
    Country
    US
    Email
    [email protected]
    Phone
    724 8162019

    Products

    Device Name Product Code
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    System, Imaging, Pulsed Echo, Ultrasonic IYO

    Proprietary Names

    C9-4v EPIQ 5 Diagnostic Ultrasound System EPIQ 7G Diagnostic Ultrasound System L12-4 C10-4ec X5-1 L18-5 L12-3 L12-5 50 EPIQ 5C Diagnostic Ultrasound System S5-1 X7-2t D2tcd D2cwc Affiniti 70 Diagnostic Ultrasound System VL13-5 3D9-3v C9-2 D5cwc S8-3 Affiniti 50G Diagnostic Ultrasound System L15-7io EPIQ 7 Diagnostic Ultrasound System C8-5 S12-4 Affiniti 50C Diagnostic Ultrasound System Affiniti 70G Diagnostic Ultrasound System Affiniti 50W Diagnostic Ultrasound System X7-2 S7-3t V6-2 C6-2 X6-1 BP10-5ec C10-3v EPIQ 7W Diagnostic Ultrasound System EPIQ 5W Diagnostic Ultrasound System C5-1 Affiniti 70W Diagnostic Ultrasound System EPIQ 7C Diagnostic Ultrasound System S4-2 Affiniti 50 Diagnostic Ultrasound System EPIQ 5G Diagnostic Ultrasound System S8-3t Affiniti 70C Diagnostic Ultrasound System X8-2t

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device