Spacelabs Medical Integrated Multiparameter Module 90496

• 2 recalls, same reason

  • Terminated Z-2342-2008 FDA Unclassified (pre-2012) ·initiated 22 Jul 2008
  • Terminated Z-2343-2008 FDA Unclassified (pre-2012) ·initiated 22 Jul 2008

  Potential for module to fail to obtain a NIBP reading on hypertension patients.

• • Terminated Z-2314-2008 FDA Unclassified (pre-2012) ·initiated 2 Jul 2008

  Intermittent contact of temperature probe adaptors can cause a loss of temperature monitoring which can cause a delay in care when an alarm is missed.

510(k) Number

K972502 ↗

FDA Product Code

DSI

Device Class

Class II

Regulation

21 CFR Part 870.1025

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Spacelabs Medical, Inc. →

• What is the Spacelabs Medical Integrated Multiparameter Module 90496 used for?

  The Spacelabs Medical Integrated Multiparameter Module 90496 is a patient monitoring component that acquires, processes, and displays multiple physiologic signals, including cardiac rhythm and other cardiovascular parameters. It serves as the core processing unit for the Spacelabs patient care monitoring system, providing detector and alarm functions for arrhythmia and other critical events.

• How is the Spacelabs Multiparameter Module 90496 supplied and what is its intended use?

  The module is supplied as a reusable component intended for integration with the Spacelabs PCMS platform in hospital care settings. It is designed to be part of a comprehensive patient monitoring system rather than used as a standalone device.

• What is the regulatory status of the Spacelabs Multiparameter Module 90496?

  The module was cleared by the FDA through a traditional 510(k) submission (K972502) and is classified as a Class II device. It is identified by product code DSI and is regulated under the FDA 510(k) clearance process, conforming to the cardiovascular advisory committee requirements.

• Can the Spacelabs Multiparameter Module 90496 be reused or is it single-use?

  The Spacelabs Multiparameter Module 90496 is supplied as a reusable module designed for integration with the Spacelabs patient care monitoring system in hospital settings. It is intended for multiple uses within a healthcare facility as part of a monitoring system.