510(k) Report

Devices descending from K994346

3 later devices reach Abl 77 PH, Blood Gas and Electrolyte Analysis System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K051804ABL80 Flex AnalyzerSendx Medical, Inc.200524
+2K080370Abl 80 CO-OX SystemSendx Medical, Inc.200814
+3K151856ABL80 FLEX CO-OX with AQURE connectivitySendx Medical, Inc.201503