510(k) Report

Devices descending from K210593

3 later devices reach Onera Sleep Test System (Onera STS) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260050WRAP SystemHuneo, LLC20260—
+1K223573Onera Sleep Test System (Onera STS)Onera B.V.20231—
+2K243220Onera STS 2 (ONERA STS 2)Onera B.V.20250—