BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Life Scope® PT BSM-1700 Series

    Reg #: 3013501110 · FEI: 3013501110 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    Nihon Kohden Corporation - Tokorozawa establishment Advanced Technology Center
    Registration Number
    3013501110
    FEI Number
    3013501110
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1-1-6 Kusunokidai, Tokorozawa-Shi, Saitama
    City
    Tokorozawa Saitama
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K220976

    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

    US Agent

    Business Name
    NIHON KOHDEN AMERICA, LLC.
    Contact Name
    Charlemagne Chua
    Address
    15353 Barranca Pkwy, --
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US
    Email
    [email protected]
    Phone
    949 3303964

    Products

    Device Name Product Code
    Stimulator, Nerve, Peripheral, Electric KOI
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX

    Proprietary Names

    Life Scope® PT BSM-1700 Series

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198