510(k) Report

Devices descending from K162131

3 later devices reach ExSpiron 1Xi through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173181ExSpiron 1XiRespiratory Motion, Inc.20182—
+2K260226ElintMAX Respiratory Monitor (ElintMAX Monitor A1)Amptron Medical, Inc.20260—
+2K192595ExSpiron 2XiRespiratory Motion20190—