← Product Code [KOI](/submissions/AN/subpart-c%E2%80%94monitoring-devices/KOI) · K955026

# AS/3 NMT MODULE (K955026)

_Datex Medical Instrumentation, Inc. · KOI · Apr 28, 1997 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/KOI/K955026

## Device Facts

- **Applicant:** Datex Medical Instrumentation, Inc.
- **Product Code:** [KOI](/submissions/AN/subpart-c%E2%80%94monitoring-devices/KOI.md)
- **Decision Date:** Apr 28, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.2775
- **Device Class:** Class 2
- **Review Panel:** Anesthesiology

## Indications for Use

The product is designed to be used for monitoring relaxation of patient during and after anesthesia and for regional block stimulation for nerve location. The intended environment of use is anesthesia department, including operation rooms (OR) and post-anesthesia care units (PACU) etc.

## Device Story

AS/3 M-NMT module; component of AS/3 anesthesia monitoring system. Function: neuromuscular transmission monitoring and nerve location via regional block stimulation. Operation: module stimulates patient; measures response; transmits data to AS/3 anesthesia or compact monitor central unit. Central unit software calculates NMT values, displays data, manages trends, and provides monitoring features. Used in OR and PACU by anesthesia clinicians. Output assists in assessing patient relaxation levels and guiding nerve block procedures.

## Clinical Evidence

No clinical data provided; bench testing only.

## Technological Characteristics

Modular anesthesia monitoring component; hardware-based stimulation and response measurement; integrates with AS/3 anesthesia or compact monitor central unit; software-driven calculation and display.

## Regulatory Identification

An electrical peripheral nerve stimulator (neuromuscular blockade monitor) is a device used to apply an electrical current to a patient to test the level of pharmacological effect of anesthetic drugs and gases.

## Submission Summary (Full Text)

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{0}

K955086

510(k) SUMMARY

23.02.96

APR 28 1997

Datex Division
Instrumentarium Corp.
P.O. Box 446
FIN-00101 Helsinki
Finland
Tel: +358 0 39411
Fax: +358 0 1463310

Contact person: Rauno Ruoho

# PRODUCT NAMES

Device name:  $\mathrm{AS} / 3^{\mathrm{TM}}$  M-NMT

Common name: Neuromuscular transmission Device

# DESCRIPTION OF THE DEVICE

The AS/3™ NMT Module is a part of the modular anesthesia monitoring system AS/3™. It provides relaxation measurement of patient.

The product is designed to be used for monitoring relaxation of patient during and after anesthesia and for regional block stimulation for nerve location. The intended environment of use is anesthesia department, including operation rooms (OR) and post-anesthesia care units (PACU) etc.

The NMT measurement hardware is in the NMT module. The NMT Module stimulates the patient controlled by the AS/3™ Anaesthesia or Compact Monitor central unit. Then the NMT Module measures the response of the stimulation and sends it to the AS/3™ Anaesthesia or Compact Monitor central unit. The AS/3™ monitor software receives the responses from the NMT module, calculates the NMT values, displays the NMT values, handles NMT trending and NMT monitor features.

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/KOI/K955026](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/KOI/K955026)

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