510(k) Report

Devices descending from K945585

10 later devices reach Coman (R) CU-11 Model Number 82-6634 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152670DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface CablesMedos International SARL20160—
+1K062584Pressio Icp Monitoring SystemSophysa SA200782
+2K162108Pressio 2 ICP Monitoring SystemSophysa SA201713
+2K112017Raumedic Icp Monitoring SystemRaumedic AG20116—
+2K103206Raumedic- Icp-Monitoring SystemRaumedic AG20117—
+3K252241Pressio 3 Multi-parameter Neuromonitoring SystemSophysa20260—
+3K250285Neurovent-P (092946-003); Neurovent (092956-003); Neurovent-Ifd-R (095317-003)…Raumedic AG20250—
+3K130529Raumedic-Pto-Monitoring-SystemRaumedic AG20134—
+3K120252Raumedic-Icp-Temp-Monitoring-SystemRaumedic AG20125—
+4K171666MPR2 logO DATALOGGERRaumedic AG20170—