510(k) Report

Devices descending from K990125

509 later devices reach HP Viridia Component Monitoring System, Model Rev. K through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+10K260910EndoTool IV Cloud 1.0Glooko, Inc.20260—
+10K252981EmbraceMiniEmpatica S.r.l.20251—
+10K250515EpiMonitorEmpatica S.r.l.20250—
+10K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+10K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+10K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+10K171423Nasal Alar SpO2 SensorXhale, Inc.201711
+11K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar…Philips Medizin Systeme20260—