510(k) Report

Devices descending from K102562

103 later devices reach Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K250515EpiMonitorEmpatica S.r.l.20250—
+8K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+8K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—