510(k) Report

Devices descending from K791006

3 later devices reach Smart Bilectrodes through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K962115Cambridge Heart HI-Res Ecg ElectrodeCambridge Heart, Inc.19962—
+2K013615Micro-Induction 1000 SystemHarbinger Medical, Inc.20021—
+3K090249Modification to: Micro-Induction 1000 SystemHarbinger Medical, Inc.20090—