510(k) Report

Devices descending from K133769

3 later devices reach 3B Resmart Bpap 25A, BMC Resmart Bpap 25A through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201620Luna® G3 BPAP 25A3B Medical, Inc.20212—
+2K213169BPAP SystemBMC Medical Co., Ltd.20220—
+2K212263Luna G3 BPAP System3B Medical, Inc.20220—