510(k) Report

Devices descending from K955015

108 later devices reach Zymed Holter Scanner Model 2010 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K251494Eko Foundation Analysis Software with Transformers (EFAST)Eko Health, Inc.20250—
+9K240901StethophoneSparrow Acoustics, Inc.20241—
+9K212008Reveal LINQ Insertable Cardiac MonitorMedtronic, Inc.20210—
+9K201865Biomonitor III, Biomonitor IIImBiotronik, Inc.20203—
+10K252595Stethophone ProSparrow Acoustics, Inc.20250—
+10K221856BIOMONITOR IIIm, BIOMONITOR IIIBiotronik, Inc.20222—
+11K230375Biomonitor IVBiotronik, Inc.20231—
+12K261074Biomonitor IV (471155)Biotronik, Inc.20260—