510(k) Report

Devices descending from K970098

3 later devices reach E100 Series SPO2 Sensors through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K992211SPO2 Wrap SensorEpic Medical Equipment Services, Inc.19990—
+1K992092Stat-Shell Disposable SPO2 SensorEpic Medical Equipment Services, Inc.19990—
+1K990082Epic SPO2 Finger Sensor, Model E403-09, E412-09 and Epic Oximeter Cable, Model E710-09Epic Medical Equipment Services, Inc.19990—