BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Life Scope® G7H

    Reg #: 8030229 · FEI: 3002807739 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    51
    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
    K203435

    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

    Life Scope® G7H Life Scope® G5 Plus Life Scope® G5 Life Scope® G5 X Life Scope® G5 Max YS-116P0 SSD Expansion Board QI-152P Side option board SB-950P Battery Pack Nihon Kohden Life Scope® G5 Bedside Monitoring System Life Scope® G5 Min KG-150P Wall mount kit (for CU-171R, CU-172R) Life Scope® G5L Life Scope® G5 H Nihon Kohden Life Scope® G7 Bedside Monitoring System QI-152P Side option board for CU-152R DH-190P Unit holder CU-171R Core unit Life Scope® G7 with (DAU) Data Acquisition Module G5-HD Life Scope® G7 High Acuity Monitor Life Scope® G5 Lite Life Scope® G5L, Life Scope® G5 All-in-one Patient Monitor DZ-150P Handle (for CU-151R, CU-152R) CU-172R Core unit Life Scope® G7 H DH-154P IF holder AA-174P Multi Amp Unit QI-151P Rear option board for CU-151R/CU-152R DH-157P Adapter Life Scope® G5-HD QS-116PA Software Kit WS-151P Recorder Unit DH-151P Adapter WS-171P Recorder Unit CU-171R/CU-172R DH-153P Recorder holder DM-150P Stand (for CU-171R, CU-172R) QM-151P SD Card QI-171P Rear option board CU-171R/CU-172R DH-150P Unit holder JA-170P Data Acquisition Unit DH-152P Channel adapter SB-970P Battery Pack DH-155P Holder KC-150P Cart (for CU-171R, CU-172R) DH-158P GF holder QS-127PA Software Kit DH-159P Unit holder CU-152R Core unit DH-156P Unit holder CU-151R Core unit

    Establishment Types

    Manufacture Medical Device