510(k) Report

Devices descending from K053388

6 later devices reach Model 840 Ventilator with Proportional Assist Ventilation Plus Software Option through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103578Philips NM3 Respiratory Monitor with VentassistRespironics Novametrix, LLC20114—
+1K062793Servo-I Ventilator System, Model 64 87 800 E407E; Nava OptionMaquet Critical Care AB20070—
+2K222897Enlight 2100Timpel S.A.20232—
+2K192584BEACON Caresystem Model 00002144Mermaid Care A/S20190—
+3K250464Enlight 2100 (TPL-E2103-0)Timpel S.A.20250—
+3K243765LuMon (TM) SystemSentec AG20250—