510(k) Report

Devices descending from K010029

105 later devices reach Home Health Monitoring System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K161686F&P InfoSmartFisher & Paykel Healthcare, Ltd.20170—
+6K132618Onetouch RevealLifescan, Inc.20130—
+6K122361T:Connect Data Management SystemTandem Diabetes Care, Inc.20130—
+6K103643Ascot Home Medical Monitoring System (HMMS)Ascot Technologies, Inc.20110—
+7K203594EyeCTesterNeuro-Eye Diagnostic Systems, LLC20220—