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Tof-Guard Transmission Monitor

by Biometer Intl. A/S

510(k) K925159

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK925159 Date1 Sep 1993ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
KOI
Device Class
Class II
Regulation
21 CFR Part 868.2775
Advisory Committee
Anesthesiology
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-Guard Transmission Monitor is a peripheral electric nerve stimulator. It is designed to provide neuromuscular transmission monitoring.

This device is classified as a Class 2 medical device under regulation 868.2775. It has received FDA 510(k) clearance under the reference number K925159.

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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 function of the Tof-Guard Transmission Monitor?

    The Tof-Guard Transmission Monitor is a peripheral electric nerve stimulator. It is specifically designed to provide neuromuscular transmission monitoring for patients.

  • What is the regulatory classification of this device?

    The Tof-Guard Transmission Monitor is classified as a Class 2 medical device under regulation 868.2775. It has received FDA 510(k) clearance under the reference number K925159.

  • Which medical specialty is this device associated with?

    This device is associated with the anesthesiology medical specialty, as indicated by its classification under the anesthesiology advisory committee.