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FDA 510(k)

Neuromuscular Transmission Monitor TOF3D (2510091)

K-Number: K250887 · 2025-10-21

ApplicantMIPM Mammendorfer Institut für Physik und Medizin GmbH
Decision Date2025-10-21
Product CodeKOI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Neuromuscular Transmission Monitor TOF3D (2510091) is a medical device manufactured by MIPM Mammendorfer Institut für Physik und Medizin GmbH. It received FDA 510(k) clearance on 2025-10-21 under approval number K250887. The device is classified under product code KOI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Neuromuscular Transmission Monitor TOF3D (2510091)?

Neuromuscular Transmission Monitor TOF3D (2510091) is a medical device that received FDA 510(k) clearance on 2025-10-21. It is manufactured by MIPM Mammendorfer Institut für Physik und Medizin GmbH. The 510(k) number is K250887.

When was Neuromuscular Transmission Monitor TOF3D (2510091) approved by the FDA?

Neuromuscular Transmission Monitor TOF3D (2510091) received FDA 510(k) clearance on 2025-10-21, under approval number K250887.

What company makes Neuromuscular Transmission Monitor TOF3D (2510091)?

Neuromuscular Transmission Monitor TOF3D (2510091) is manufactured by MIPM Mammendorfer Institut für Physik und Medizin GmbH.

What is the FDA product code for Neuromuscular Transmission Monitor TOF3D (2510091)?

The FDA product code for Neuromuscular Transmission Monitor TOF3D (2510091) is KOI.

Related Clinical Trials

NCT05452226 Neuromuscular Electrical Stimulation in COPD/Community Acquired Pneumonia COMPLETED NCT06472284 TetraGraph in Rocuronium Infusions COMPLETED NCT06458023 TOF Monitoring Using the TetraGraph in Patients Less Than 1 Year of Age COMPLETED NCT06409611 Muscle Effects Of Neuromuscular Electrostimulation In Mechanically Ventilated Patients In An Icu COMPLETED NCT07133412 An Evaluation of the Neuromuscular Junction in Neonates Using the TetraGraph NOT_YET_RECRUITING NCT05632107 Comparison of an Acceleromyography- and Electromyography-based Neuromuscular Monitor With TOF-Watch ® Monitor RECRUITING

Other Devices by MIPM Mammendorfer Institut für Physik und Medizin GmbH

K212434Neuromuscular Transmission Monitor TOF3D

Related Devices (Code: KOI)

K162048EZstim*III Peripheral Nerve Stimulator/Nerve LocatorHalyard Health - Irvine K172690ToFscanIdmed K172843TwitchView SystemBlink Device Corporation K190795Tetragraph Neuromuscular Transmission MonitorSenzime AB K192958TwitchView SystemBlink Device Company K213316Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEMNihon Kohden Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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