BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    DZ-170P

    Reg #: 8030229 · FEI: 3002807739 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    133
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    NIHON KOHDEN TOMIOKA PRODUCTION CENTER
    Registration Number
    8030229
    FEI Number
    3002807739
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1-1 Tajino
    City
    TOMIOKA-SHI Gunma
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K080342

    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

    Proprietary Names

    DZ-170P YP-714T QM-600P JL-631P TG-101T YP-711T TL-201T QI-373P IF-948P IF-914P TL-271T3 QF-907P TL-535U IF-919P IF-925P JG-900P SC-170R IF-917P JP-900P MU-631RA IF-943P WS-671P YJ-910P QI-610PA YG-214T QI-320PA QF-901P JT-900P A/FQW-50-2-100 IF-912P QI-631P QP-038P IF-946P IF-954P CD-237P JL-639P YG-101T JL-632P NK-ASPECT-BISX QF-903P QI-672P IF-950P MU-671RA QI-430PA YG-122T TL-274T QI-632P IF-916P YN-920P TL-273T3 JP-920P IF-923P YN-921P IF-19004 IF-928P IF-956P SB-170P IF-932P QF-904P QS-028PA IF-951P IF-922P RY-910PA YS-096P3 TG-900P YS-096P6 JA-694PA IF-927P YG-211T IF-957P JL-500P1 IF-920P YP-710T SB-671P TL-271T IF-913P QF-908P YG-213T QF-902P TL-274T3 YS-096P2 JL-650P IF-955P IF-942P IF-937P IF-961P TL-272T3 QF-909P IF-963P QI-600P JL-630P JP-910P IF-935P BJ-900PA TL-220T TR-900P TL-631T3 YN-900P JT-950P YP-713T BR-906PA IF-939P YJ-671P YS-096P5 IF-944P QF-921P MU-651RA YP-715T JL-900P JO-900P YN-901P IF-930P QS-065PA YG-001P YP-712T YG-111T TL-052S QS-042P YN-990P QF-801P QF-911P YJ-672P YS-63015 DH-170P QI-634P BR-903PA DH-220P AA-674P YJ-920P IF-958P QI-671P JC-906PA TL-062S

    Establishment Types

    Manufacture Medical Device