BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    CardiMax FX-8000/9000 Series ECG

    Reg #: 9611031 · FEI: 3002807019 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    FUKUDA DENSHI CO., LTD.
    Registration Number
    9611031
    FEI Number
    3002807019
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3-39-4, HONGO,
    City
    BUNKYO-KU Tokyo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K173226

    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

    US Agent

    Business Name
    FUKUDA DENSHI USA, INC.
    Contact Name
    Doug Blakely
    Address
    17725 N.E. 65TH ST., BLDG. C
    City
    Redmond
    State
    WA
    ZIP
    98052
    Country
    US
    Email
    [email protected]
    Phone
    210 2404521

    Products

    Device Name Product Code
    Electrocardiograph DPS

    Proprietary Names

    CardiMax FX-8000/9000 Series ECG

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device