510(k) K190795

Tetragraph Neuromuscular Transmission Monitor by Senzime AB — Product Code KOI

K190795 is an FDA 510(k) premarket notification submitted by Senzime AB for the device "Tetragraph Neuromuscular Transmission Monitor". The FDA issued a decision of Substantially Equivalent on October 18, 2019. The device falls under product code KOI (Stimulator, Nerve, Peripheral, Electric), a Class II device regulated under 21 CFR 868.2775. Senzime AB has at least 2 other 510(k) clearances on record.