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 SYSTEM by Nihon Kohden Corporation — Product Code KOI

K213316 is an FDA 510(k) premarket notification submitted by Nihon Kohden Corporation for the device "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". The FDA issued a decision of Substantially Equivalent on December 29, 2021. The device falls under product code KOI (Stimulator, Nerve, Peripheral, Electric), a Class II device regulated under 21 CFR 868.2775. Nihon Kohden Corporation has at least 10 other 510(k) clearances on record.