510(k) Report

Devices descending from K031849

9 later devices reach Spectrum Patient Monitor, Model 0998-00-0500-Xxxxx through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K091834Passport V Monitor, Model 0998-00-6100Datascope Corp., Patient Monitoring Division200902
+1K062098Spectrum Monitor, Model 0998-00-1000-XxxxxDatascope Corp.20077—
+2K132229Omni Patent MonitorsInfinium Medical20142—
+2K102004Endeavour Monitoring SystemMindray DS USA, Inc.201033
+3K153079Axeo 3 Patient MonitorAxeo Medical Technologies, LLC20160—
+3K142244Cleo Patient MonitorInfinium Medical201501
+3K132026V Series Monitoring System, 12.1 Dcu/V12 and 21.0 Dcu/V21Mindray DS USA, Inc.201321
+4K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20151—
+5K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201602