510(k) Report

Devices descending from K151006

4 later devices reach EarlySense Central Display Station (CDS) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212622Zyter RPMZyter, Inc.20220—
+1K202497Aulisa Multiple Patient Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20202—
+2K242842ANNE View, Central HubSibel Health, Inc.20251—
+3K243837iBSMIorbit Digital Technologies Private Limited20250—