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As/3 Nmt Module

by Datex Medical Instrumentation, Inc. 510(k)

Active United States

510(k) K955026

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK955026 Date28 Apr 1997ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

1 recall · FDA

    • Terminated Z-1640-2014 FDA Class II initiated 9 Apr 2014

    When the E-NMT-01 module is used in conjunction with the ElectroSensor, the Neuromuscular Transmission (NMT) values may indicate a deeper level of muscle relaxation than the actual level of muscle relaxation. In the clinical situation visual movements of the hand are seen after TOF (Train of Four) stimulation, but the patient monitor shows no counts, or counts are not corresponding to the actual a

Specification

510(k)

510(k) Number
FDA Product Code
KOI
Device Class
Class II
Regulation
21 CFR Part 868.2775
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

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