BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FD DS-5000 Series Telemetry

    Reg #: 3031158 · FEI: 3000215024 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    FUKUDA DENSHI USA, INC.
    Registration Number
    3031158
    FEI Number
    3000215024
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    17725 N.E. 65TH ST., BLDG. C
    City
    REDMOND
    State
    WA
    ZIP
    98052
    Country
    US

    Regulatory Submissions

    510(k) Number
    K050363

    Owner / Operator

    Firm Name
    FUKUDA DENSHI CO., LTD.
    Operator Number
    9028352
    Address
    3-39-4, HONGO, BUNKYO-KO, --
    City
    TOKYO
    State
    JP-NOTA
    Postal Code
    113
    Country
    JP

    Products

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

    Proprietary Names

    FD DS-5000 Series Telemetry

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198