Nellcor Receives FDA Clearance for Symphony Monitoring System Modules

Strategic Insights -

Nellcor Incorporated has received marketing clearance from the U.S. Food and Drug Administration for the first two modules of the NELLCOR SYMPHONY monitoring system, the N-3000 pulse oximeter and the N-3100 noninvasive blood pressure monitor. The NELLCOR SYMPHONY monitoring system is designed to address the growing need for patient safety monitoring outside traditional critical care settings, primarily in the hospital general care floor, alternate care sites, and mobile environments. The system's advanced signal processing and alarm management technology allow for exceptional performance in high-motion, low perfusion patient environments. International sales of the N-3000 and N-3100 began in late fiscal 1994, and have been well-received in Europe.

Key Takeaways:

  • The NELLCOR SYMPHONY monitoring system is designed to provide patient safety monitoring outside traditional critical care settings, including hospital general care floors, alternate care sites, and mobile environments.
  • The system's first two modules, the N-3000 pulse oximeter and the N-3100 noninvasive blood pressure monitor, have received FDA marketing clearance.
  • The N-3000 pulse oximeter features advanced signal processing and alarm management technology, allowing for exceptional performance in high-motion, low perfusion patient environments.
  • The N-3100 blood pressure monitor offers advanced noninvasive blood pressure monitoring, measuring systolic, diastolic, and mean arterial blood pressure, as well as pulse rate in automatic, manual, and stat modes.
  • The system's modules are designed to work together as standalone monitors or as part of a combined unit, and can be used with any combination of planned NELLCOR SYMPHONY modules.
  • International sales of the N-3000 and N-3100 began in late fiscal 1994, approximately a year before the FDA clearance in the United States.
  • Nellcor Inc. is the leading producer of pulse oximeters used in hospitals for continuous measurement of patient oxygen status, with a broad line of oximetry sensors and a sensor recycling program.
  • Nellcor Inc. designs, manufactures, and markets high-performance monitoring equipment, sensors, and accessories for patient safety and management throughout the hospital, in emergency care, and in the home.

Statistics:

  • International sales of the N-3000 and N-3100 began in late fiscal 1994.
  • The N-3000 pulse oximeter features advanced signal processing and alarm management technology.
  • The N-3100 blood pressure monitor measures systolic, diastolic, and mean arterial blood pressure, as well as pulse rate in automatic, manual, and stat modes.
  • Nellcor Inc. is the leading producer of pulse oximeters used in hospitals for continuous measurement of patient oxygen status.
  • Nellcor's line of oximetry sensors is the broadest in the medical equipment industry, including adhesive and reusable sensors, as well as a sensor recycling program.

Sources:

  • Nellcor Incorporated, press release, May 30, 1995.
  • Business Wire, "Nellcor Receives FDA Clearance for Symphony Monitoring System Modules", May 30, 1995.
  • Nellcor Incorporated, "Nellcor Inc. Overview".