510(k) Report

Devices descending from K002089

2 later devices reach Rosetta-LT/Rosetta-RX through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K040663Telenable Ems SystemMolex, Inc.20040—
+1K013533Ems Telemedicine Option (for Gems Series 4000)General Devices20020—