510(k) Report

Devices descending from K111116

3 later devices reach Engstrom Carestation, Engstrom Pro, Models 1505-9000-000, 1505-9003-000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142679Carescape R860Datex-Ohmeda, Inc.20151Class I
+1K140575Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc.20150—
+2K210384Carescape R860Datex-Ohmeda, Inc.20210—