510(k) Report

Devices descending from K051367

9 later devices reach Patient Monitor, Models Dash 3000, 4000 and 5000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K073462Modification to Dash 3000, 4000, 5000 Monitor and AccessoriesGe Medical Systems Information Technologies200889
+2K083750Capnostat / Capnoflex CO2 SystemGe Medical Systems Information Technologies20090—
+2K080461Star ST and Arrhythmia Software, Release J.0Philips Medical Systems20086—
+3K152305Nihon Kohden Afib Detection Program QP-039PNihon Kohden Corporation20160—
+3K101521ST/AR ST and Arrhythmia Software Model: Release K.OPhilips Medical Systems20104—
+4K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201602
+4K151812Patient Monitors Various ModelsPhilips Medical Systems20160—
+4K150082Panorama Patient Monitoring NetworkShenzhen Mindray Bio-Medical Electronics Co., Ltd.201501
+4K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20151—