FDA 510(k) Applications Submitted by Nihon Kohden Corporation

FDA 510(k) Number Submission Date Device Name Applicant
K142624 09/16/2014 Neuromaster G1 MEE200 Nihon Kohden Corporation
K220976 04/04/2022 Life Scope PT BSM-1700 Series Bedside Monitor Nihon Kohden Corporation
K201949 07/13/2020 Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series Nihon Kohden Corporation
K191975 07/24/2019 Elefix V Paste for EEG & EMG Nihon Kohden Corporation
K213316 10/04/2021 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 SYSTEM Nihon Kohden Corporation
K203435 11/23/2020 Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside Monitoring System Nihon Kohden Corporation
K223567 11/29/2022 CNS-2101 Central Monitor Nihon Kohden Corporation
K190468 02/26/2019 Nihon Kohden SVM-7200 Series Vital Signs Monitor Nihon Kohden Corporation
K171765 06/14/2017 Nihon Kohden CO2 Monitor Nihon Kohden Corporation
K161860 07/06/2016 TG-970P CO2 Sensor Kit NIHON KOHDEN CORPORATION
K171124 04/17/2017 Nihon Kohden Wireless Input Unit WEE-1200 Nihon Kohden Corporation
K152305 08/14/2015 Nihon Kohden Afib Detection Program QP-039P NIHON KOHDEN CORPORATION
K163459 12/09/2016 Nihon Kohden Vital Sign Telemeter Nihon Kohden Corporation
K183529 12/19/2018 AE-120A EEG Head Set Nihon Kohden Corporation
K153707 12/23/2015 Nihon Kohden Vital Sign Telemeter NIHON KOHDEN CORPORATION
K163644 12/23/2016 Nihon Kohden QP-160AK EEG Trend Program Nihon Kohden Corporation


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