510(k) Report

Devices descending from K213882

3 later devices reach EarliPoint System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230337EarliPointEarlitec Diagnostics, Inc.20232—
+2K243891EarliPoint SystemEarlitec Diagnostics20251—
+3K253442EarliPoint AssessmentEarlitec Diagnostics20260—