510(k) Report

Devices descending from K782079

5 later devices reach Electrode System, Quik-Prep through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K023713Sonoprep Impedance Diagnostics (Idx) System, Model D1000Sontra Medical, Inc.20041—
+1K962115Cambridge Heart HI-Res Ecg ElectrodeCambridge Heart, Inc.19962—
+2K040525Sonoprep Ultrasonic Skin Permeation System and Topical Anesthetic Kit, Model D2000Sontra Medical, Inc.20040—
+2K013615Micro-Induction 1000 SystemHarbinger Medical, Inc.20021—
+3K090249Modification to: Micro-Induction 1000 SystemHarbinger Medical, Inc.20090—