510(k) Report

Devices descending from K950944

105 later devices reach Ambulatory (Holter) Recording System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K201865Biomonitor III, Biomonitor IIImBiotronik, Inc.20203—
+9K243603AeviceMDAevice Health Pte., Ltd.20250—
+9K221856BIOMONITOR IIIm, BIOMONITOR IIIBiotronik, Inc.20222—
+10K230375Biomonitor IVBiotronik, Inc.20231—
+11K261074Biomonitor IV (471155)Biotronik, Inc.20260—