510(k) Report

Devices descending from K980882

309 later devices reach Siemens SC 7000 & SC 9000 XL Infinity Modular Bedside Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K132359Mri Patient Monitoring SystemInvivo Corporation20130—
+11K260211Dashboard (P007000)Hill-Rom, Inc.20260—
+11K250349Vista CMSShanghai Draeger Medical Instrument Co., Ltd.20260—
+11K252250Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model…Shanghai Draeger Medical Instrument Co., Ltd.20260—
+11K250179Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)Edan Instruments, Inc.20250—
+11K242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLC20250—
+11K212271smart-syncNorthh Medical GmbH20220—
+11K183387M3290B Patient Information Center iXPhilips Medical Systems20190—
+11K173203Athena GTX Device Management Suite (ADMS) SoftwareAthena Gtx20180—