510(k) Report

Devices descending from K062584

8 later devices reach Pressio Icp Monitoring System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162108Pressio 2 ICP Monitoring SystemSophysa SA201713
+1K112017Raumedic Icp Monitoring SystemRaumedic AG20116—
+1K103206Raumedic- Icp-Monitoring SystemRaumedic AG20117—
+2K252241Pressio 3 Multi-parameter Neuromonitoring SystemSophysa20260—
+2K250285Neurovent-P (092946-003); Neurovent (092956-003); Neurovent-Ifd-R (095317-003)…Raumedic AG20250—
+2K130529Raumedic-Pto-Monitoring-SystemRaumedic AG20134—
+2K120252Raumedic-Icp-Temp-Monitoring-SystemRaumedic AG20125—
+3K171666MPR2 logO DATALOGGERRaumedic AG20170—