510(k) Report

Devices descending from K152995

8 later devices reach BioMonitor 2-AF, BioMonitor 2-S through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190548BIOMONITOR III, Remote Assistant IIIBiotronik, Inc.20195—
+1K171514BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, SetBiotronik, Inc.20170—
+1K170628BioMonitor 2-AF, BioMonitor 2-SBiotronik, Inc.20170—
+2K200444Biomonitor III, Biomonitor IIImBiotronik, Inc.20204—
+3K201865Biomonitor III, Biomonitor IIImBiotronik, Inc.20203—
+4K221856BIOMONITOR IIIm, BIOMONITOR IIIBiotronik, Inc.20222—
+5K230375Biomonitor IVBiotronik, Inc.20231—
+6K261074Biomonitor IV (471155)Biotronik, Inc.20260—