510(k) Report

Devices descending from K213463

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220028NightOwlEctosense NV20222—
+2K243268TipTraQ (TTQ001)Pranaq Pte., Ltd.20250—
+2K222579Belun Sleep System BLS-100Belun Technology Company Limited20230—