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    FDA Registration Active 🇺🇸 United States

    Nihon Kohden America Fulfillment Center

    Reg #: 3030154814 · FEI: 3030154814 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    61
    Establishment Types
    2
    Classifications
    7

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    Registration Details

    Registration Name
    Nihon Kohden America Fulfillment Center
    Registration Number
    3030154814
    FEI Number
    3030154814
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    20091 Ellipse, Suite 100
    City
    Foothill Ranch
    State
    CA
    ZIP
    92610
    Country
    US

    Regulatory Submissions

    510(k) Number
    K050833

    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
    Standard Polysomnograph With Electroencephalograph OLV
    Full-Montage Standard Electroencephalograph GWQ
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Electrocardiograph DPS
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
    Transmitters And Receivers, Physiological Signal, Radiofrequency DRG
    Stimulator, Electrical, Evoked Response GWF

    Proprietary Names

    TL-220T TL-062S TL-052S JE-921A TL-201T TG-921T3 CARBON DIOXIDE MONITOR, MODEL OLG-2800A YG-211T TG-101T TG-900P JG-900P YG-101T SB-901D YZ-041H2 KD-105D BA-903D ECG-1350A ECG-1250A SERIES CARDIOFAX ECG-1250A NKB-301V DI-015D ECG-1350A SERIES CARDIOFAX KH-100D DI-014D TL-631T3 A/NTX-DISP TL-272T3 ZM-530PA ZM-521PA ZM-541PA TL-271T TL-274T YN-990P TL-273T3 BR-913PA ZS-940PA YP-504P ZM-520PA YP-944P A/NTX2-POUCH BR-916PA ZM-531PA BR-906PA TL-271T3 TL-274T3 BR-903PA ZM-540PA YP-503P YP-943P MULTIPLE PATIENT RECEIVER ORG-9700A YG-122T QP-101BK MEE-1000A NEUROMASTER TG-980P CO2 Sensor Kit with Smart Connector TG-980P1 CO2 Sensor Kit with Smart Connector TG-980P CO2 Sensor Kit TG-980P TG-980P1 CO2 Sensor Kit with Smart Cable TG-980P1 CO2 Sensor Kit TG-980P1 TG-980P CO2 Sensor Kit with Smart Cable

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device