510(k) Report

Devices descending from K051629

3 later devices reach Bleas Esiriuc Anaesthsia System, Models 3000, 2000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101850Spacelabs Bleasesirius Anesthesia WorkstationSpacelabs Healthcare, Ltd.20112Class I
+2K112729BLEASE700/900 Series VentilatorsSpacelabs Healthcare201201
+2K113051Spacelabs Arkon Anesthesia WorkstationSpacelabs Healthcare20120Class I