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FDA 510(k)

Tetragraph Neuromuscular Transmission Monitor

K-Number: K190795 · 2019-10-18

ApplicantSenzime AB
Decision Date2019-10-18
Product CodeKOI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Tetragraph Neuromuscular Transmission Monitor is a medical device manufactured by Senzime AB. It received FDA 510(k) clearance on 2019-10-18 under approval number K190795. 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 Tetragraph Neuromuscular Transmission Monitor?

Tetragraph Neuromuscular Transmission Monitor is a medical device that received FDA 510(k) clearance on 2019-10-18. It is manufactured by Senzime AB. The 510(k) number is K190795.

When was Tetragraph Neuromuscular Transmission Monitor approved by the FDA?

Tetragraph Neuromuscular Transmission Monitor received FDA 510(k) clearance on 2019-10-18, under approval number K190795.

What company makes Tetragraph Neuromuscular Transmission Monitor?

Tetragraph Neuromuscular Transmission Monitor is manufactured by Senzime AB.

What is the FDA product code for Tetragraph Neuromuscular Transmission Monitor?

The FDA product code for Tetragraph Neuromuscular Transmission Monitor 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 Senzime AB

K220530Tetragraph Neuromuscular Transmission Monitor

Related Devices (Code: KOI)

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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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