Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Neuromuscular Transmission Monitor TOF3D

K-Number: K212434 · 2022-05-05

ApplicantMIPM Mammendorfer Institut für Physik und Medizin GmbH
Decision Date2022-05-05
Product CodeKOI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Neuromuscular Transmission Monitor TOF3D is the device name listed in this FDA 510(k) record. The listed applicant is MIPM Mammendorfer Institut für Physik und Medizin GmbH. It received FDA 510(k) clearance on 2022-05-05 under 510(k) number K212434. 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?

Neuromuscular Transmission Monitor TOF3D is a medical device that received FDA 510(k) clearance on 2022-05-05. The listed applicant is MIPM Mammendorfer Institut für Physik und Medizin GmbH. The 510(k) number is K212434.

When did Neuromuscular Transmission Monitor TOF3D receive FDA 510(k) clearance?

Neuromuscular Transmission Monitor TOF3D received FDA 510(k) clearance on 2022-05-05, under 510(k) number K212434.

Who is the listed applicant for Neuromuscular Transmission Monitor TOF3D?

The FDA 510(k) record lists MIPM Mammendorfer Institut für Physik und Medizin GmbH as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for Neuromuscular Transmission Monitor TOF3D 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.

NCT06458023TOF Monitoring Using the TetraGraph in Patients Less Than 1 Year of AgeCOMPLETEDNCT06472284TetraGraph in Rocuronium InfusionsCOMPLETEDNCT07133412An Evaluation of the Neuromuscular Junction in Neonates Using the TetraGraphNOT_YET_RECRUITING

Other records listing MIPM Mammendorfer Institut für Physik und Medizin GmbH 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.

K250887Neuromuscular Transmission Monitor TOF3D (2510091)

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.

↑