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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 the device name listed in this FDA 510(k) record. The listed applicant is Senzime AB. It received FDA 510(k) clearance on 2019-10-18 under 510(k) 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. The listed applicant is Senzime AB. The 510(k) number is K190795.

When did Tetragraph Neuromuscular Transmission Monitor receive FDA 510(k) clearance?

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

Who is the listed applicant for Tetragraph Neuromuscular Transmission Monitor?

The FDA 510(k) record lists Senzime AB as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07133412An Evaluation of the Neuromuscular Junction in Neonates Using the TetraGraphNOT_YET_RECRUITINGNCT06458023TOF Monitoring Using the TetraGraph in Patients Less Than 1 Year of AgeCOMPLETEDNCT06472284TetraGraph in Rocuronium InfusionsCOMPLETEDNCT07706504Comparison of Two Quantitative EMG Monitors for Deep Neuromuscular Block in Laparoscopic/Robotic and VATS SurgeryRECRUITINGNCT07750405A Comparative Study of the Next-Generation TetraGraph® and Mechanomyography Neuromuscular Monitors in Clinical SettingsNOT_YET_RECRUITING

Other records listing Senzime AB as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261098TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017)K220530Tetragraph Neuromuscular Transmission Monitor

Related Devices (Code: KOI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261098TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017)Senzime ABK250887Neuromuscular Transmission Monitor TOF3D (2510091)MIPM Mammendorfer Institut für Physik und Medizin GmbHK243339WiTOFIdmedK242525iTOF®Nerbio Medical Software Platforms, Inc.K220530Tetragraph Neuromuscular Transmission MonitorSenzime ABK220976Life Scope PT BSM-1700 Series Bedside MonitorNihon 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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