510(k) Report

Devices descending from K051804

2 later devices reach ABL80 Flex Analyzer through their predicates, nearest generation first.

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