510(k) Report

Devices descending from K182626

2 later devices reach OEC One through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240828OEC One ASDGe Hualun Medical Systems Co., Ltd.20241—
+2K253269OEC One CFDGe Hualun Medical Systems Co., Ltd.20250—