510(k) K220976

Life Scope PT BSM-1700 Series Bedside Monitor by Nihon Kohden Corporation — Product Code KOI

K220976 is an FDA 510(k) premarket notification submitted by Nihon Kohden Corporation for the device "Life Scope PT BSM-1700 Series Bedside Monitor". The FDA issued a decision of Substantially Equivalent on July 21, 2022. 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.