510(k) Report

Devices descending from K900607

5 later devices reach MK5 Detector & Alarm, Arrhythmia W/Software 2.11 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K004017H-ScribeMortara Instrument, Inc.200142
+2K042002Synescope, Easyscope, Synecom, HolterreaderEla Medical, Inc.20043—
+3K193177CER-SCardiocalm20202—
+4K213861CER-SCardiocalm Srl20221—
+5K243312CER-SCardiocalm Srl20250—