BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TL-271T3

    Reg #: 3030154814 · FEI: 3030154814 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    29
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Nihon Kohden America Fulfillment Center
    Registration Number
    3030154814
    FEI Number
    3030154814
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    20091 Ellipse, Suite 100
    City
    Foothill Ranch
    State
    CA
    ZIP
    92610
    Country
    US

    Regulatory Submissions

    510(k) Number
    K043517

    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, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT

    Proprietary Names

    TL-271T3 A/NTX-DISP ZM-540PA TL-220T YP-944P ZM-530PA TL-271T ZM-521PA TL-062S A/NTX2-POUCH TL-274T3 YP-943P ZM-531PA BR-906PA TL-272T3 YP-503P YN-990P TL-273T3 TL-201T TL-631T3 ZM-541PA ZM-520PA TL-274T YP-504P BR-913PA BR-916PA TL-052S ZS-940PA BR-903PA

    Establishment Types

    Manufacture Medical Device