510(k) Report

Devices descending from K191320

5 later devices reach Slow Wave DS8 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233754AIO BreatheAiomega, LLC20241—
+1K230532RADx Intraoral Appliance for Snoring and Sleep ApneaAchaemenid, LLC20231—
+1K220330Soundly Anti Snoring DeviceGreystone Ip, Ltd.20220—
+2K254304iNOS intraoral biosensorAchaemenid, LLC20260—
+2K252525AIO BreatheAiomega, LLC20250—