510(k) Report

Devices descending from K103168

2 later devices reach B-CARE5 (B-CARE5 Sensor Module, Venous Sensor, Holder for Measuring Head) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202154B-CaptaLivanova Deutschland, GmbH20211—
+2K232291Essenz HLM, Essenz ILBMLivanova Deutschland, GmbH202301