510(k) Report

Devices descending from K083158

5 later devices reach Exalis, Software Version 1.15 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093379TCX-I-DV Remote Care Management SystemBl Healthcare, Inc.20104—
+2K131739Nxstage Connected Health SystemNxstage Medical, Inc.20131—
+2K101078BL Healthcare Remote Care Management SystemBl Healthcare, Inc.20101—
+3K181991NxStage Connected Health SystemNxstage Medical, Inc.20180—
+3K113493TCX-I Remote Care Management SystemBl Healthcare, Inc.20110—