510(k) Report

Devices descending from K191031

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242224Happy Health Home Sleep TestHappy Health, Inc.20250—
+1K213463NightOwlEctosense NV20213—
+2K220028NightOwlEctosense NV20222—
+3K243268TipTraQ (TTQ001)Pranaq Pte., Ltd.20250—
+3K222579Belun Sleep System BLS-100Belun Technology Company Limited20230—