510(k) Report

Devices descending from K210139

1 later device reach Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251591Holter ECG and ABP system (HolterABP)Edan Instruments, Inc.20260—