BEUDAMED
    FDA Registration Active 🇺🇸 United States

    21369A (Omni II)

    Reg #: 3017894900 · FEI: 3017894900 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    22
    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
    K014191

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

    Proprietary Names

    21369A (Omni II) 21228B (D1914V) S4-2 21321A (C3540) C9-4ec 21360A (L5035) 21373B (C5040) 21422A C8-4v C5-2 21221B (C1914C) 21330A (S4) 21350A (S8) 21475A C6-3 21359A (L7535) C8-5 21390A (15-61) EnVisor Diagnostic Ultrasound System 21223B (D5014V) 21380A (S12) S4

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility