510(k) Report

Devices descending from K896396

5 later devices reach Mida System, Models 1000/1100 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K042002Synescope, Easyscope, Synecom, HolterreaderEla Medical, Inc.20043—
+1K023414Mida Algorithm Rev. BOrtivus AB20030—
+2K193177CER-SCardiocalm20202—
+3K213861CER-SCardiocalm Srl20221—
+4K243312CER-SCardiocalm Srl20250—