510(k) Report

Devices descending from K102525

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103345Breathe Technologies Ventilator and Accessories (BT-V2S)Breathe Technologies, Inc.20112—
+2K131562Breathe Niov Ventilation SystemBreathe Technologies20141—
+3K152664TAV SystemNew Aera, Inc.20160—