510(k) K212434

Neuromuscular Transmission Monitor TOF3D by MIPM Mammendorfer Institut für Physik und Medizin GmbH — Product Code KOI

K212434 is an FDA 510(k) premarket notification submitted by MIPM Mammendorfer Institut für Physik und Medizin GmbH for the device "Neuromuscular Transmission Monitor TOF3D". The FDA issued a decision of Substantially Equivalent on May 5, 2022. The device falls under product code KOI (Stimulator, Nerve, Peripheral, Electric), a Class II device regulated under 21 CFR 868.2775. MIPM Mammendorfer Institut für Physik und Medizin GmbH has at least 1 other 510(k) clearance on record.