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Smart Alarm Interface

by Boxview, LLC 510(k)

Active United States

510(k) K193421

Overview

The Smart Alarm Interface is a system and network communication device that provides real-time alerts and monitoring for physiological monitors. It is designed to integrate with clinical systems to enhance patient monitoring and safety during procedures.

The device is intended for use by professional clinical personnel and relies on proper operation of both the communication systems at the healthcare facility and the display devices used. It is supplied as a reusable device and is MRI safe. The Smart Alarm Interface has FDA 510(k) clearance with product code MSX and is classified as a Class II device.

AI-generated from registry data, 21 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK193421 Date30 Oct 2020ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
MSX
Device Class
Class II
Regulation
21 CFR Part 870.2300
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Questions

  • What is the Smart Alarm Interface used for?

    The Smart Alarm Interface is a system and network communication device designed to provide real-time alerts and monitoring for physiological monitors, integrating with clinical systems to enhance patient monitoring and safety during procedures by delivering timely notifications to healthcare staff.

  • Is the Smart Alarm Interface reusable or single-use?

    The Smart Alarm Interface is supplied as a reusable device, meaning it can be used multiple times after appropriate cleaning and maintenance, as indicated in the device description, which specifies its reusable nature for ongoing clinical use.

  • Is the Smart Alarm Interface safe to use in MRI environments?

    Yes, the Smart Alarm Interface is MRI safe, meaning it does not pose a risk or interfere with magnetic resonance imaging procedures, allowing it to be used in or near MRI suites without compromising safety or image quality.