510(k) Report

Devices descending from K964055

2 later devices reach Flexi-Site (E203-01)/ Flexi-Fit (E300) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K012333Flexi-Site SP02 Ear SensorEpic Medical Equipment Services, Inc.20010—
+1K992211SPO2 Wrap SensorEpic Medical Equipment Services, Inc.19990—