510(k) Report

Devices descending from K891104

125 later devices reach CD Telemetry Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K252981EmbraceMiniEmpatica S.r.l.20251—
+9K250515EpiMonitorEmpatica S.r.l.20250—
+9K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+9K243837iBSMIorbit Digital Technologies Private Limited20250—
+9K242352Accurate Mini Non-invasive blood pressure monitor (AMB-001)Accurate Meditech, Inc.20250—
+9K242842ANNE View, Central HubSibel Health, Inc.20251—
+9K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+9K240251ANNE ChestSibel Health, Inc.20240—
+9K240305ANNE LimbSibel Health, Inc.20240—
+9K222010Biobeat Platform-2 and BB-613WP PatchBiobeat Technologies, Ltd.20221—
+9K213230T3 Platform SoftwareEtiometry, Inc.202212—
+9K192757VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D…Vitalconnect, Inc.20201—
+10K231276SmartCardia 7L PlatformSmartcardia SA20230—
+10K223578T3 Platform softwareEtiometry, Inc.20232—
+10K213423T3 Platform softwareEtiometry, Inc.20232—
+10K222463EchoGo Heart FailureUltromics Limited20227—
+11K251293CardioVisionIcardio.Ai20250—
+11K241479Etiometry Platform (DAV 5.4 RAE 9.2)Etiometry, Inc.20251—
+11K240860EchoGo Amyloidosis (1.0)Ultromics Limited20242—
+11K240013EchoGo Heart Failure (2.0)Ultromics Limited20240—
+11K223905Vivio® LVEDP SystemAvicena, LLC20230—
+11K231335Cleerly ISCHEMIACleerly, Inc.20230—
+12K254066Etiometry PlatformEtiometry, Inc.20260—
+12K250151Us2.caEko.Ai Pte Ltd. D/B/A Us2.Ai20250—
+12K243866InVision Precision Cardiac AmyloidInVision Medical Technology Corporation20250—