BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TL-274T

    Reg #: 2080783 · FEI: 2080783 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    32
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    NIHON KOHDEN AMERICA, INC.
    Registration Number
    2080783
    FEI Number
    2080783
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    15353 Barranca Pkwy
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US

    Regulatory Submissions

    510(k) Number
    K011918

    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(With Arrhythmia Detection Or Alarms) MHX

    Proprietary Names

    TL-274T YG-101T BR-906PA YN-921P TL-052S JC-906PA BR-903PA BSM-2354A TG-900P TG-101T BR-913PA JL-900P JP-910P TL-062S TL-271T JG-900P YG-122T NIHON KOHDEN BSM-2300A SERIES BEDSIDE MONITOR BR-916PA YG-111T TL-220T JP-900P BSM-2351A TL-201T BSM-2301A YN-901P NK-ASAAPPLIANCE JP-920P TL-631T3 YN-990P YN-900P YN-920P

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198