510(k) Report

Devices descending from K001388

4 later devices reach Data Master Perfusion Monitoring System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202154B-CaptaLivanova Deutschland, GmbH20211—
+1K103168B-CARE5 (B-CARE5 Sensor Module, Venous Sensor, Holder for Measuring Head)Sorin Group Deutschland GmbH20112—
+1K092463Sorin B-CARE5 for the Stockert S5 SystemSorin Group Deutschland GmbH200931
+2K232291Essenz HLM, Essenz ILBMLivanova Deutschland, GmbH202301