510(k) Report

Devices descending from K153387

2 later devices reach Luna CPAP and Auto CPAP System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253044RXiBreeze PAP System (RXiBreeze 20C)Resvent Medical Technology Co., Ltd.20260—
+1K211155Auto CPAP SystemBMC Medical Co., Ltd.20220—