510(k) Report

Devices descending from K062098

7 later devices reach Spectrum Monitor, Model 0998-00-1000-Xxxxx through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132229Omni Patent MonitorsInfinium Medical20142—
+1K102004Endeavour Monitoring SystemMindray DS USA, Inc.201033
+2K153079Axeo 3 Patient MonitorAxeo Medical Technologies, LLC20160—
+2K142244Cleo Patient MonitorInfinium Medical201501
+2K132026V Series Monitoring System, 12.1 Dcu/V12 and 21.0 Dcu/V21Mindray DS USA, Inc.201321
+3K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20151—
+4K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201602