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FDA grants 510(k) clearance to Zoll Propaq M monitor

Zoll Medical has received the US Food and Drug Administration (FDA) 510(k) clearance to market and begin distribution of the new Propaq M Monitor, for deployable military medicine and air medical operations worldwide.

The Propaq M monitor, a new ultra-lightweight, compact device, combines all advanced capabilities and features of the Propaq monitors which include 12-lead monitoring, a third invasive pressure channel, extensive trending and data collection, a large high-contrast color display with 4-waveform capability.

The other features include a night vision goggle (NVG) mode for military and air medical night operations, and a user-removeable battery that will operate all the physiological parameters for over 7.5 hours.

The new capabilities were designed into a new small, lightweight, rugged package nearly 5lbs lighter than currently deployed technology.

Zoll said that the Propaq M is a companion monitor version of the FDA-cleared Propaq MD transport monitor/defibrillator having common interface that facilitates a seamless transition and operator readiness.

ZOLL president Jonathan Rennert said that these two products, when combined, will meet the most expansive needs of the military for patient care in difficult environments and the FDA clearance of both devices is a significant milestone for ZOLL.

“Given the success of earlier Welch Allyn Propaq monitors and ZOLL M Series CCT (Critical Care Transport) monitor/defibrillators, we are well-positioned to capture a significant share of the military market as the need to replace and upgrade devices creates substantial business opportunities,” Rennert said.