510(k) Report

Devices descending from K080461

6 later devices reach Star ST and Arrhythmia Software, Release J.0 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152305Nihon Kohden Afib Detection Program QP-039PNihon Kohden Corporation20160—
+1K101521ST/AR ST and Arrhythmia Software Model: Release K.OPhilips Medical Systems20104—
+2K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201602
+2K151812Patient Monitors Various ModelsPhilips Medical Systems20160—
+2K150082Panorama Patient Monitoring NetworkShenzhen Mindray Bio-Medical Electronics Co., Ltd.201501
+2K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20151—