BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FUKUDA DENSHI USA, INC.

    Reg #: 3031158 · FEI: 3000215024 · Expires 2026
    View on FDA
    Products
    18
    Proprietary Names
    28
    Establishment Types
    2
    Classifications
    16

    Registration Details

    Registration Name
    FUKUDA DENSHI USA, INC.
    Registration Number
    3031158
    FEI Number
    3000215024
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    17725 N.E. 65TH ST., BLDG. C
    City
    REDMOND
    State
    WA
    ZIP
    98052
    Country
    US

    Regulatory Submissions

    510(k) Number
    K981066

    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
    LOS
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Transducer, Heart Sound JOO
    Phonocardiograph DQC
    Electrocardiograph DPS
    Detector And Alarm, Arrhythmia DSI
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    NSX
    Medical Device Data System OUG
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Dislodger, Stone, Basket, Ureteral, Metal FFL
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
    Oximeter DQA
    Monitor, Breathing Frequency BZQ
    Computer, Blood-Pressure DSK

    Proprietary Names

    Fukuda Denshi 4000 Series ECG Fukuda Denshi DSX Series Telemetry Transmitter Fukuda Denshi LX-Series Telemetry Transmitter Fukuda Denshi VaSera 1000/2000 Series CardiMax FX-8000/9000 Series ECG DynaScope DS-5000 Series Central Station FD DS-5000 Series Telemetry FD DS-7100 Series Patient Monitor FD UF-750 3D Ultrasound Fukuda Denshi US-750 XT Ultrasound Fukuda Denshi 5000 Series Telemetry Transmitter FD DMS Software Fukuda Denshi DS-7000 Monitor Fukuda Denshi UF-Series Ultrasound Fukuda Denshi CVW Series Data Management System DynaScope DS-8100 Series Sigma 5000 Series Ultrasound Fukuda Denshi UltraSound UF-760AG Fukuda Denshi DynaScope 7000 Series Patient Monito Fukuda Denshi FCP Series ECG Fukuda Denshi HG Series Pulse Oximeter Fukuda Denshi UF-800 Series Ultrasound FD DS-5700 CS Fukuda Denshi Central Station Series Monitor DynaScope DS-8000 Series Patient Monitors FD DS-5000 CS FD DS-7141 Series Monitor FD UF-5800 Ultrasound

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device