510(k) Report

Devices descending from K930806

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K162855Reveal LINQMedtronic, Inc.2017111
+9K163460Reveal LINQ Insertable Cardiac MonitorMedtronic, Inc.20170—
+10K262735LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)Medtronic, Inc.20260—
+10K252284eMurmur Heart AICsd Labs20250—
+10K251494Eko Foundation Analysis Software with Transformers (EFAST)Eko Health, Inc.20250—
+10K240901StethophoneSparrow Acoustics, Inc.20241—
+10K212008Reveal LINQ Insertable Cardiac MonitorMedtronic, Inc.20210—
+10K201865Biomonitor III, Biomonitor IIImBiotronik, Inc.20203—
+11K252595Stethophone ProSparrow Acoustics, Inc.20250—
+11K221856BIOMONITOR IIIm, BIOMONITOR IIIBiotronik, Inc.20222—
+12K230375Biomonitor IVBiotronik, Inc.20231—
+13K261074Biomonitor IV (471155)Biotronik, Inc.20260—