BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TL-220T

    Reg #: 2080783 · FEI: 2080783 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    22
    Establishment Types
    2
    Classifications
    2

    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
    K153707

    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
    Transmitters And Receivers, Physiological Signal, Radiofrequency DRG

    Proprietary Names

    TL-220T TL-271T3 TL-272T3 TL-052S TL-535U TL-631T1 TL-062S TL-273T BR-943PA GZ-120P TL-631T3 BR-933PA TL-274T3 TL-273T3 TL-051S TL-272T TL-271T TL-260T GZ-130P TL-061S TL-201T TL-274T

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device