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Omni-Trak Model 3150 Series Patient Monitoring System

by Invivo Research, Inc.

510(k) K971840

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 · Traditional NumberK971840 Date4 Mar 1998ClearedStatusActive

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  • Withdrawn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
MHX
Device Class
Class II
Regulation
21 CFR Part 870.1025
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 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 Omni-Trak Model 3150 Series Patient Monitoring System is a physiological patient monitor with arrhythmia detection or alarms. It is classified as a Monitor, Physiological, Patient (with Arrhythmia Detection Or Alarms). The device is used to monitor patient vital signs during magnetic resonance imaging (MRI) scans.

The Omni-Trak Model 3150 Series Patient Monitoring System is supplied by Invivo Research, Inc. and has been cleared by the FDA under the product code MHX. It is a Class II device with special controls. The device has a registration number and is intended for use in cardiovascular applications.

Other devices from Invivo Research, Inc.

See all devices from Invivo Research, Inc. →

Questions

AI-generated answers, 28 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 Omni-Trak 3150 Series used for?

    The Omni-Trak 3150 Series is used to monitor patient vital signs during magnetic resonance imaging (MRI) scans, particularly in cardiovascular applications.

  • Is the Omni-Trak 3150 Series a single-use or reusable device?

    The device data does not specify whether the Omni-Trak 3150 Series is single-use or reusable, but it is classified as a Class II device with special controls.

  • What type of clearance does the Omni-Trak 3150 Series have?

    The Omni-Trak 3150 Series has been cleared by the FDA under the product code MHX, with a Traditional clearance type and a decision description of Substantially Equivalent.

  • What are the storage requirements for the Omni-Trak 3150 Series?

    The device data does not provide specific storage requirements for the Omni-Trak 3150 Series, but it is recommended to follow the manufacturer's instructions for storage and handling.

  • What is the regulatory classification of the Omni-Trak 3150 Series?

    The Omni-Trak 3150 Series is classified as a Monitor, Physiological, Patient (with Arrhythmia Detection Or Alarms), with a regulation number of 870.1025.