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Tof-Cuff Monitor

by Rgb Medical Devices SA

510(k) K181894

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Abbreviated NumberK181894 Date9 May 2019ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DXN
Device Class
Class II
Regulation
21 CFR Part 870.1130
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Tof-Cuff monitor is a system for the measurement of non-invasive blood pressure and neuromuscular transmission. It is intended to monitor these physiological parameters in adult patients during surgery and issue related alarms.

This device is supplied as a monitor that functions by applying a cuff similar to standard blood pressure measurement equipment. It is classified as a Class II device under product code DXN and has received FDA 510(k) clearance.

Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary clinical use of the TOF-Cuff monitor?

    The TOF-Cuff monitor is designed to measure two specific physiological parameters in adult patients during surgical procedures: non-invasive blood pressure and neuromuscular transmission. It provides continuous monitoring and includes alarm functions to alert clinicians to changes in these parameters.

  • How does the TOF-Cuff monitor function?

    The device functions by applying a cuff to the patient, utilizing a mechanism similar to standard non-invasive blood pressure measurement equipment to gather physiological data.

  • What is the regulatory status of the TOF-Cuff monitor?

    The TOF-Cuff monitor has received FDA 510(k) clearance under K-number K181894. It is classified as a Class II device under product code DXN.