510(k) Report

Devices descending from K180098

3 later devices reach SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243767SV600, SV800 VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+1K201874Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator…Maquet Critical Care AB20210Class I
+1K192604Servo-air 4.0 Ventilator SystemMaquet Critica Care AB20200Class I