510(k) Report

Devices descending from K211305

6 later devices reach ANNE One through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223711ANNE OneSibel Health, Inc.20234—
+1K221530ANNE PediatricSibel, Inc.20220—
+2K243837iBSMIorbit Digital Technologies Private Limited20250—
+2K242842ANNE View, Central HubSibel Health, Inc.20251—
+2K240251ANNE ChestSibel Health, Inc.20240—
+2K240305ANNE LimbSibel Health, Inc.20240—