FDA 510(k) Applications Submitted by Sandra Gadeyne

FDA 510(k) Number Submission Date Device Name Applicant
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


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