510(k) Report

Devices descending from K052049

7 later devices reach Philips 12-Lead Algorithm through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132068Philips DXL 12/16-Lead Ecg AlgorithmPhilips Medical Systems20130—
+1K073376Philips Ecg AlgorithmPhilips Medical Systems20085—
+2K101521ST/AR ST and Arrhythmia Software Model: Release K.OPhilips Medical Systems20104—
+3K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201602
+3K151812Patient Monitors Various ModelsPhilips Medical Systems20160—
+3K150082Panorama Patient Monitoring NetworkShenzhen Mindray Bio-Medical Electronics Co., Ltd.201501
+3K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20151—