510(k) Report

Devices descending from K964408

123 later devices reach Poseidon Cardiac Monitoring System (PCMS) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K181991NxStage Connected Health SystemNxstage Medical, Inc.20180—
+6K163664Health-e-Connect System with IDAAlr Technologies20170—
+6K170798Dictum HealthDictum Health, Inc.20175—
+6K161686F&P InfoSmartFisher & Paykel Healthcare, Ltd.20170—
+6K121738Myvisiontrack (TM)Vital Art and Science Incorporated20133—
+6K123229Remote Presence System, Model RP-VitaIntouch Health, Inc.20120—
+6K101806Aidera Diasend SystemAidera AB20102—
+6K093789Intouch DiabetesSymcare Personalized Health Solutions, Inc.20100—
+6K091296Polytel Gma, Models PWR-08-67, PWR-08-07, PWR-08-09Polymap Wireless20090—
+6K083263Symcare Diabetes Management ProgramSymcare Personalized Health Solutions, Inc.20091—
+6K081499Health Manager, Version 1.1Biocomfort Diagnostics GmbH & Co. KG20090—
+6K083331Confidant, Model 2.6Confidant, Inc.20092—
+7K253021ANNE MaternalSibel Health, Inc.20260—
+7K192004Eko Analysis SoftwareEko Devices, Inc.20204—
+7K143211myVision Track Model 005Vital Art and Science Incorporated20152—
+7K132618Onetouch RevealLifescan, Inc.20130—
+7K122361T:Connect Data Management SystemTandem Diabetes Care, Inc.20130—
+8K213794Eko Murmur Analysis Software (EMAS)Eko Devices, Inc.20223—
+8K180895AlleyeOculocare Medical AG20181—
+9K251494Eko Foundation Analysis Software with Transformers (EFAST)Eko Health, Inc.20250—
+9K240901StethophoneSparrow Acoustics, Inc.20241—
+9K203594EyeCTesterNeuro-Eye Diagnostic Systems, LLC20220—
+10K252595Stethophone ProSparrow Acoustics, Inc.20250—