510(k) Report

Devices descending from K000168

2 later devices reach CS/3 Critical Care Monitor with S-ICU99(a) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K021376Datex-Ohmeda S/5 Critical Care Monitor with L-ICU02 and L-ICU02A SoftwareDatex-Ohmeda20021—
+2K071889Datex-Ohmeda S/5 Critical Care Monitor with L-ICU05 and L-ICU05A SoftwareGE Healthcare20080—