510(k) Report

Devices descending from K173403

2 later devices reach GEM Premier 5000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203790GEM Premier 5000Instrumentation Laboratory CO2021125
+2K223608GEM Premier 7000 with IQM3Instrumentation Laboratory Company202302