510(k) Report

Devices descending from DEN130033

8 later devices reach Cognivue through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150154ANAM Test System: Military BatteryVista Lifesciences, Inc.20157—
+2K183241BrainScope TBI (Model: Ahead 400)Brainscope Company, Inc.20193—
+2K161068Ahead 300Brainscope Company, Inc.20166—
+3K190815BrainScope TBIBrainscope Company, Inc.20192—
+3K181179BrainScope OneBrainscope Company, Inc.20185—
+4K231914Nurochek-II SystemHeadsafe Mfg Pty, Ltd.20231—
+4K181785Modified BrainScope OneBrainscope Company, Inc.20180—
+5K243426Nurochek-Pro SystemHeadsafe Mfg Pty, Ltd.20250—