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510(k) K250887

Device
Neuromuscular Transmission Monitor TOF3D (2510091)
Applicant
MIPM Mammendorfer Institut für Physik und Medizin GmbH
510(k) number
K250887
Product code
KOI
Decision
Substantially Equivalent (SESE)
Decision date
2025-10-21
Date received
2025-03-25
Regulation
868.2775
Classification name
Stimulator, Nerve, Peripheral, Electric
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Sebastian Wörl
Address
Oskar-Von-Miller St. 6-7 Mammendorf DE 82291 82291

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KOI#

510(k), Device, Applicant table
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K192958TwitchView SystemBlink Device Company2020-04-02
K190795Tetragraph Neuromuscular Transmission MonitorSenzime AB2019-10-18
K172690ToFscanIdmed2018-05-31
K172843TwitchView SystemBlink Device Corporation2018-03-29
K162048EZstim*III Peripheral Nerve Stimulator/Nerve LocatorHalyard Health - Irvine2016-12-05
K051635DATEX-OHMEDA S/5 NEUROMUSCULAR TRANSMISSION MODULE, E-NMT AND ACCESSORIESGE Healthcare2005-07-15
K042003INFINITY TRIDENT NMT PODDraeger Medical Systems, Inc.2004-09-01