510(k) Report

Devices descending from K201620

2 later devices reach Luna® G3 BPAP 25A through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213169BPAP SystemBMC Medical Co., Ltd.20220—
+1K212263Luna G3 BPAP System3B Medical, Inc.20220—