510(k) Report

Devices descending from K220028

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

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