510(k) Report

Devices descending from K201054

4 later devices reach SOMNOscreen plus through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241288Noxturnal WebNox Medical Ehf20242—
+1K240700HomeSleepTest (HST, HST REM+)Somnomedics GmbH20240—
+2K261747Report StudioBeacon Biosignals, Inc.20260—
+2K260585Noxturnal WebNox Medical Ehf20260—