510(k) Report

Devices descending from K123149

9 later devices reach Servo-I Ventilator System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153688Edi Catheter ENFitMaquet Critical Care AB201711
+1K151814SERVO-U Ventilator System, SERVO-n Ventilator SystemMaquet Critical Care AB20154—
+1K142679Carescape R860Datex-Ohmeda, Inc.20151Class I
+2K253715Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi…Maquet Critical Care AB20260—
+2K210384Carescape R860Datex-Ohmeda, Inc.20210—
+2K180098SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1Maquet Critical Care AB20193—
+3K243767SV600, SV800 VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+3K201874Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator…Maquet Critical Care AB20210Class I
+3K192604Servo-air 4.0 Ventilator SystemMaquet Critica Care AB20200Class I