510(k) Report

Devices descending from K103345

2 later devices reach Breathe Technologies Ventilator and Accessories (BT-V2S) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131562Breathe Niov Ventilation SystemBreathe Technologies20141—
+2K152664TAV SystemNew Aera, Inc.20160—