BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    TL-273T3

    Reg #: 3013501110 · FEI: 3013501110 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    48
    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
    K163459

    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
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Transmitters And Receivers, Physiological Signal, Radiofrequency DRG

    Proprietary Names

    TL-273T3 TL-631T1 JL-030U1 YP-817P TL-271T3 YP-711T YP-841T YP-810P YP-814P TL-260T YN-980S TL-274T YP-811P YP-815P YS-112P4 YP-843T TL-631T3 YP-715T YN-981S YP-816P YP-845T YP-712T GZ-140P BR-906PA YP-844T BR-903PA YP-710T TL-220T TL-052S YP-842T TL-274T3 YP-813P TL-201T TL-273T BR-943PA TL-062S TL-051S BR-933PA YP-840T TL-272T YP-812P YP-713T JL-030U2 TL-272T3 TL-061S YP-714T TL-535U TL-271T

    Establishment Types

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