510(k) Report

Devices descending from K161624

5 later devices reach MicrO2 OSA Device with Micro-Recorder through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202529ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient…Prosomnus Sleep Technologies, Inc.20202—
+1K172859Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with…Prosomnous Sleep Technologies20171—
+2K252765ProSomnus RPMO2 OSA Device (RPMO2 OSA)Prosomnus Sleep Technologies20261—
+2K190687Twilite ApplianceStephen J Harkins, Dds, PC20190—
+3K254304iNOS intraoral biosensorAchaemenid, LLC20260—