510(k) K201949

Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series by Nihon Kohden Corporation — Product Code KOI

K201949 is an FDA 510(k) premarket notification submitted by Nihon Kohden Corporation for the device "Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series". The FDA issued a decision of Substantially Equivalent on May 2, 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.