510(k) Report

Devices descending from K004017

4 later devices reach H-Scribe through their predicates, nearest generation first.

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