510(k) Report

Devices descending from K163045

2 later devices reach Omron HEM-6400T-Z Wrist Blood Pressure Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182481HEM-6410T-ZM Wrist Blood Pressure MonitorOmron Healthcare, Inc.20181—
+2K242568Wrist Blood Pressure Monitor (OHMS11, OHMS12)Shenzhen Zhongkemingwang Telecommunications Software Corp.20250—