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Nihon Kohden Corporation

FDA 510(k) & PMA Approved Devices — 19 products

Total Devices19
Categories12
Latest FDA decision2026-08-12
TypeNumberDevice NameCodeDateActions
510(k) K251641 GF-310R Multigas Unit (GF-310R)CCK2026-08-12 View
510(k) K260747 YP-710T Series NIBP Cuff;YP-840T Series Disposable CuffDXQ2026-05-06 View
510(k) K251366 EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A)OLT2025-10-09 View
510(k) K243956 TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)CCK2025-06-10 View
510(k) K223567 CNS-2101 Central MonitorMSX2023-07-31 View
510(k) K220976 Life Scope PT BSM-1700 Series Bedside MonitorKOI2022-07-21 View
510(k) K213316 Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEMKOI2021-12-29 View
510(k) K203435 Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside Monitoring SystemMHX2021-07-16 View
510(k) K201949 Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 SeriesKOI2021-05-02 View
510(k) K191975 Elefix V Paste for EEG & EMGGYB2020-02-07 View
510(k) K190468 Nihon Kohden SVM-7200 Series Vital Signs MonitorMWI2019-05-28 View
510(k) K183529 AE-120A EEG Head SetOMC2019-03-19 View
510(k) K171765 Nihon Kohden CO2 MonitorCCK2017-10-11 View
510(k) K171124 Nihon Kohden Wireless Input Unit WEE-1200GWQ2017-08-25 View
510(k) K163644 Nihon Kohden QP-160AK EEG Trend ProgramOMA2017-05-19 View
510(k) K163459 Nihon Kohden Vital Sign TelemeterMHX2017-04-04 View
510(k) K161860 TG-970P CO2 Sensor KitCCK2017-02-24 View
510(k) K153707 Nihon Kohden Vital Sign TelemeterMHX2016-09-02 View
510(k) K152305 Nihon Kohden Afib Detection Program QP-039PDSI2016-04-08 View
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