510(k) Report

Devices descending from K011597

2 later devices reach Smartmonitor 2, Model 4000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K032403Smartmonitor 2 Professional Series (PS)Respironics, Inc.200311
+2K061256Smartmonitor 2PSRespironics, Inc.200603