510(k) Report

Devices descending from K021230

6 later devices reach HERO through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142551QANS (Quantitative Autonomic Nervous System) Monitoring SystemHhssystems, LLC20150—
+1K081473Hero, Version 2.0Medical Predictive Science Corp.20082—
+1K062068Intelwave Heart Rate Variability System, Version 1.0Intelwave, LLC20061—
+1K040313HRV ToolsDel Mar Reynolds Medical, Ltd.20040—
+2K111601HEROMedical Predictive Science Corp.20111—
+3K180242HeRO Symphony, HeRO ES, HeRO solo/duetMedical Predictive Science Corporation20180—