BEUDAMED
    FDA Registration Active 🇺🇸 United States

    L18-5

    Reg #: 3017894900 · FEI: 3017894900 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    33
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Philips Ultrasound LLC
    Registration Number
    3017894900
    FEI Number
    3017894900
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    222 Jacobs Street
    City
    Cambridge
    State
    MA
    ZIP
    02141
    Country
    US

    Regulatory Submissions

    510(k) Number
    K160807

    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

    L18-5 X7-2t L12-5 50 D2cwc C10-3v EPIQ 7 Diagnostic Ultrasound System BP10-5ec L12-4 V6-2 C9-2 Affiniti 70 Diagnostic Ultrasound System C8-5 L12-3 C9-4v Affiniti 30 Diagnostic Ultrasound System C5-1 3D9-3v C10-4ec C6-2 X5-1 D2tcd Affiniti 50 Diagnostic Ultrasound System L15-7io EPIQ 5 Diagnostic Ultrasound System S5-1 D5cwc S8-3 VL13-5 S7-3t S4-2 S12-4 X7-2 X6-1

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility