510(k) Report

Devices descending from K063484

4 later devices reach Patient Data Handler & Devices (PDH&D) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083221Aidera DiasendAidera AB20093—
+2K101806Aidera Diasend SystemAidera AB20102—
+3K132618Onetouch RevealLifescan, Inc.20130—
+3K122361T:Connect Data Management SystemTandem Diabetes Care, Inc.20130—