510(k) Report

Devices descending from K033304

12 later devices reach Modification to Dash 3000/4000 Patient Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052544Pulse Oximeter Adapter CablesAmerican I.V. Products, Inc.20060—
+1K051367Patient Monitor, Models Dash 3000, 4000 and 5000Ge Medical Systems Information Technologies200591
+1K040458Modification to Dash 3000/4000 Patient MonitorGe Medical Systems Information Technologies200401
+2K073462Modification to Dash 3000, 4000, 5000 Monitor and AccessoriesGe Medical Systems Information Technologies200889
+3K083750Capnostat / Capnoflex CO2 SystemGe Medical Systems Information Technologies20090—
+3K080461Star ST and Arrhythmia Software, Release J.0Philips Medical Systems20086—
+4K152305Nihon Kohden Afib Detection Program QP-039PNihon Kohden Corporation20160—
+4K101521ST/AR ST and Arrhythmia Software Model: Release K.OPhilips Medical Systems20104—
+5K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201602
+5K151812Patient Monitors Various ModelsPhilips Medical Systems20160—
+5K150082Panorama Patient Monitoring NetworkShenzhen Mindray Bio-Medical Electronics Co., Ltd.201501
+5K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20151—