FDAnews
www.fdanews.com/articles/209329-medtronic-gets-510k-clearance-for-resparray-patient-monitor

Medtronic Gets 510(k) Clearance for RespArray Patient Monitor

September 9, 2022

Medtronic has received 510(k) clearance for its RespArray patient monitor.

The device is intended to be combined with the Nellcor pulse oximetry and Microstream capnography, as well as electrocardiogram, noninvasive blood pressure and temperature monitoring.

It is also intended to be used for procedural sedation and medical-surgical units.

The company plans on a limited market release in the fourth quarter of this year. A full market release is expected in early 2023.

View today's stories