510(k) Report

Devices descending from K010955

23 later devices reach BMT Anscore Health Management System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080884QHRV 1 - Health Assessment SystemMedtechs, LLC20083—
+1K070795Sphygmocor Cardiovascular Management SystemAtcor Medical Pty, Ltd.200716—
+1K062068Intelwave Heart Rate Variability System, Version 1.0Intelwave, LLC20061—
+2K142551QANS (Quantitative Autonomic Nervous System) Monitoring SystemHhssystems, LLC20150—
+2K122129Sphygmocor XcelAtcor Medical20126—
+2K110603Hypertension Management Software Claient Server (HMS-CS)I.E.M. GmbH20118—
+2K092809HRV AcquireWr Medical Electronics Co.20100—
+2K083735Ansha Autonomic Nervous System Health Assessment PlusMedtechs, LLC20092—
+2K081654HEM-9000AIOmron Healthcare, Inc.20080—
+2K080670Modification to Sphygmocor Cardiovascular Management SystemAtcor Medical20088—
+3K221742Conneqt PulseAtcor Medical20230—
+3K191266VitalScan ANSMedeia, Inc.20200—
+3K172431Cardiovascular AnalzyerPhysiowave, Inc.20180—
+3K151520Oscar 2Suntech Medical, Inc.201632
+3K140928ABPM7100I.E.M. GmbH20145—
+3K131916Bprosoft Casp PC SoftwareHealthstats International Pte., Ltd.20140—
+3K121266CardioscopePulsecor Limited20120—
+3K110645Bio Z Cardio Profile Hemodynamic MonitorSonosite,Inc.20110—
+3K101983Critical Care AssessmentCritical Patient Care, Inc.20101—
+4K251581Wearable Ambulatory Blood Pressure Monitor (WBP-02A)Shenzhen Hingmed Medical Instrument Co., Ltd.20260—
+4K210139Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09Edan Instruments, Inc.20211—
+4K153557ABPM 7100, Hypertension Management SoftwareI.E.M. GmbH20160—
+5K251591Holter ECG and ABP system (HolterABP)Edan Instruments, Inc.20260—