510(k) Report

Devices descending from K932098

320 later devices reach Capnomac Ultima Anesthesia Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K212008Reveal LINQ Insertable Cardiac MonitorMedtronic, Inc.20210—
+9K202189GraffitiGe Medical Systems Information Technologies, Inc.20200—
+9K201865Biomonitor III, Biomonitor IIImBiotronik, Inc.20203—
+9K163584M3290B Philips IntelliVue Information Center iXPhilips Medical Systems20172—
+10K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+10K260211Dashboard (P007000)Hill-Rom, Inc.20260—
+10K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+10K250349Vista CMSShanghai Draeger Medical Instrument Co., Ltd.20260—
+10K252250Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model…Shanghai Draeger Medical Instrument Co., Ltd.20260—
+10K252981EmbraceMiniEmpatica S.r.l.20251—
+10K250179Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)Edan Instruments, Inc.20250—
+10K250515EpiMonitorEmpatica S.r.l.20250—
+10K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+10K242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLC20250—
+10K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+10K221856BIOMONITOR IIIm, BIOMONITOR IIIBiotronik, Inc.20222—
+10K183387M3290B Patient Information Center iXPhilips Medical Systems20190—
+10K173203Athena GTX Device Management Suite (ADMS) SoftwareAthena Gtx20180—
+11K230375Biomonitor IVBiotronik, Inc.20231—
+12K261074Biomonitor IV (471155)Biotronik, Inc.20260—