BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DZ-170P

    Reg #: 2080783 · FEI: 2080783 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    133
    Establishment Types
    2
    Classifications
    1

    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
    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

    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

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device