510(k) Report

Devices descending from K961687

211 later devices reach EVITA 4 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K132530GE Datex-Ohmeda Aisys CS2 (Aisys CS^2)Datex-Ohmeda, Inc.201323
+8K122063Intellisave AX700 Anesthesia SystemPhilips Anesthesia Care20130—
+8K123125GE Datex-Ohmeda Avance CS2Datex-Ohmeda, Inc.201311Class I
+8K103345Breathe Technologies Ventilator and Accessories (BT-V2S)Breathe Technologies, Inc.20112—
+9K251661Mariana Minerva; Mariana NimbusResmed Pty, Ltd.20260—
+9K170872Aisys CS2Datex-Ohmeda, Inc.201704
+9K131562Breathe Niov Ventilation SystemBreathe Technologies20141—
+9K131945GE Datex-Ohmeda Avance CS2Datex-Ohmeda201332
+10K152664TAV SystemNew Aera, Inc.20160—
+10K151570Carestation 620/650/650CDatex-Ohmeda, Inc.20161Class I
+11K213867Carestation 750/750cDatex-Ohmeda, Inc.20230Class I