BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Fukuda Denshi HG Series Pulse Oximeter

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

    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
    K013273

    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
    Oximeter DQA

    Proprietary Names

    Fukuda Denshi HG Series Pulse Oximeter

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198