BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Life Scope® G7H

    Reg #: 2080783 · FEI: 2080783 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    51
    Establishment Types
    1
    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
    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

    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

    Complaint File Establishment per 21 CFR 820.198