510(k) Report

Devices descending from K140928

5 later devices reach ABPM7100 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153557ABPM 7100, Hypertension Management SoftwareI.E.M. GmbH20160—
+1K151520Oscar 2Suntech Medical, Inc.201632
+2K251581Wearable Ambulatory Blood Pressure Monitor (WBP-02A)Shenzhen Hingmed Medical Instrument Co., Ltd.20260—
+2K210139Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09Edan Instruments, Inc.20211—
+3K251591Holter ECG and ABP system (HolterABP)Edan Instruments, Inc.20260—