AGILENT COMPONENT MONITORING SYSTEM, AGILENT V24/26, AGILENT BIS MODULE - 77A

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

510(k) Number

K003038 ↗

FDA Product Code

OLW

Models / Variants

M1175A

76A

77A

Rev.l

M1205A

Rev.l

M1034A

Device Class

Class II

Regulation

21 CFR Part 882.1400

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Agilent Component Monitoring System, Agilent Multi-Measurement Server and Compact Portable Patient Monitor, Agilent Noni

  Class II

  FDA 510(k) K001333 Active Cleared 17 May 2000

• Agilent Component Monitoring System; Agilent Invasive Blood Pressure Module

  Class II

  FDA 510(k) K001722 Active Cleared 30 Jun 2000

• Agilent Component Monitoring System, Agilent Cardiac Output Module, Agilent Invasive Pressure Module, Model M1175A/76A

  Class II

  FDA 510(k) K002758 Active Cleared 22 Feb 2001

• What is the Agilent Component Monitoring System used for?

  The Agilent Component Monitoring System is an index-generating electroencephalograph (EEG) software designed specifically for neurological monitoring. It processes EEG signals in real-time to generate indices that help assess brain function, particularly in high-stakes environments like intensive care units or operating rooms. This aids clinicians in making informed diagnostic and therapeutic decisions by providing continuous, data-driven insights into neurological activity.

• How is the Agilent Component Monitoring System supplied, and what are its usage requirements?

  The system is supplied as a software module that integrates with compatible EEG hardware, such as the Agilent V24/26 systems or BIS modules (models M1175A/76A/77A, M1205A, and M1034A). Its usage depends on the host platform’s configuration—it can be used for single-use or multi-use scenarios, though the software itself does not impose sterility requirements beyond those of the connected EEG equipment. Proper installation and configuration follow standard medical device software guidelines.

• Is the Agilent Component Monitoring System compatible with MRI environments?

  The Agilent Component Monitoring System is not classified as MRI-safe or MRI-unsafe. Its functionality relies entirely on the specifications of the connected EEG hardware, so compatibility with MRI environments would depend on the host system’s design and certification. Always verify the host device’s MRI safety status before use in such environments.

• What models of the Agilent Component Monitoring System are available?

  The system is available in multiple software module configurations, including the Agilent V24/26, Agilent BIS Module, and specific model revisions such as M1175A/76A/77A (Rev. L), M1205A (Rev. L), and M1034A. These modules are designed to work with Agilent’s EEG hardware platforms, ensuring seamless integration for neurological monitoring applications.

• How should the Agilent Component Monitoring System be stored?

  Storage follows standard medical device software guidelines. The system should be stored in a secure, controlled environment to prevent unauthorized access or damage. Since the software is not sterile and relies on the connected EEG equipment for clinical use, no additional sterility measures are required beyond those applied to the host hardware. Always adhere to manufacturer instructions for installation and maintenance.