510(k) Report

Devices descending from K212144

3 later devices reach Remex KA6 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243864BONX805Bontech Co., Ltd.20250—
+1K243473Prorad Atlas Ultraportable; Prorad Atlas Ultraportable PlusPrognosys Medical Systems Private Limited20250—
+1K213405MINE ALNU (Model: Mine 2.1)Hdt Co., Ltd.20220—