BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Central Station

    Reg #: 2032233 · FEI: 3003142870 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    Nihon Kohden Digital Health Solutions, LLC.
    Registration Number
    2032233
    FEI Number
    3003142870
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    14 Bunsen
    City
    IRVINE
    State
    CA
    ZIP
    92618
    Country
    US

    Regulatory Submissions

    510(k) Number
    K242750

    Owner / Operator

    Firm Name
    NIHON KOHDEN CORP.
    Operator Number
    8030227
    Address
    1-31-4 NISHIOCHIAI, SHINJUKU-KU
    City
    TOKYO
    State
    JP-13
    Postal Code
    161-8560
    Country
    JP

    Products

    Device Name Product Code
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Amplifier And Signal Conditioner, Transducer Signal DRQ
    System, Network And Communication, Physiological Monitors MSX

    Proprietary Names

    Central Station

    Establishment Types

    Manufacture Medical Device