510(k) Report

Devices descending from K080274

5 later devices reach Ambulo 2400 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133989Ambulo 2400 Ambulatory Blood Pressure Monitoring SystemMortara Instrument, Inc.20144—
+2K151520Oscar 2Suntech Medical, Inc.201632
+3K251581Wearable Ambulatory Blood Pressure Monitor (WBP-02A)Shenzhen Hingmed Medical Instrument Co., Ltd.20260—
+3K210139Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09Edan Instruments, Inc.20211—
+4K251591Holter ECG and ABP system (HolterABP)Edan Instruments, Inc.20260—