510(k) Report

Devices descending from K973426

31 later devices reach Ans 2000 Ecg Monitor and Respiration Pacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080884QHRV 1 - Health Assessment SystemMedtechs, LLC20083—
+1K071168The Portable AnsiscopeDyansys, Inc.20077—
+1K991831BMT Anscore Health Management System, Model 1.1Boston Medical Technologies, Inc.199926—
+2K241217CloudHRV™ System (100-01-001)Inmedix, Inc.20250—
+2K142969ANI MonitorMdoloris Medical Systems Sas20160—
+2K123130Answatch Wrist Monitor Model TS-0411Taiwan Scientific Corporation20132—
+2K083735Ansha Autonomic Nervous System Health Assessment PlusMedtechs, LLC20092—
+2K082709Vicor PD2I Analyzer, Version 2.1Vicor Technologies, Inc.20081—
+2K070795Sphygmocor Cardiovascular Management SystemAtcor Medical Pty, Ltd.200716—
+2K993875BMT Anscore Health Management SystemBoston Medical Technologies, Inc.200017—
+3K213699CareTaker Monitor AppCaretaker Medical, LLC20220—
+3K201914HRVWatch-Mini Wrist MonitorTaiwan Scientific Corporation20210—
+3K191266VitalScan ANSMedeia, Inc.20200—
+3K122129Sphygmocor XcelAtcor Medical20126—
+3K110603Hypertension Management Software Claient Server (HMS-CS)I.E.M. GmbH20118—
+3K101867Vicor PD2I AnalyzerVicor Technologies, Inc.20110—
+3K092809HRV AcquireWr Medical Electronics Co.20100—
+3K101983Critical Care AssessmentCritical Patient Care, Inc.20101—
+3K081654HEM-9000AIOmron Healthcare, Inc.20080—
+3K080670Modification to Sphygmocor Cardiovascular Management SystemAtcor Medical20088—
+4K221742Conneqt PulseAtcor Medical20230—
+4K172431Cardiovascular AnalzyerPhysiowave, Inc.20180—
+4K151520Oscar 2Suntech Medical, Inc.201632
+4K140928ABPM7100I.E.M. GmbH20145—
+4K131916Bprosoft Casp PC SoftwareHealthstats International Pte., Ltd.20140—
+4K121266CardioscopePulsecor Limited20120—
+4K110645Bio Z Cardio Profile Hemodynamic MonitorSonosite,Inc.20110—
+5K251581Wearable Ambulatory Blood Pressure Monitor (WBP-02A)Shenzhen Hingmed Medical Instrument Co., Ltd.20260—
+5K210139Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09Edan Instruments, Inc.20211—
+5K153557ABPM 7100, Hypertension Management SoftwareI.E.M. GmbH20160—
+6K251591Holter ECG and ABP system (HolterABP)Edan Instruments, Inc.20260—