510(k) Report

Devices descending from K132206

7 later devices reach Melys Atrial Fibrillation Screening Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173872FibriCheckQompium NV20186—
+2K232804FibriCheckQompium NV20241—
+2K201208Halo AF Detection SystemLivmor20200—
+2K192415Study Watch with Irregular Pulse MonitorVerily Life Sciences, LLC20202—
+3K250233PreemptiveAI Clinical SDKMeasure Labs, Inc. (Dba Preemptiveai, Inc.)20260—
+3K213357Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse MonitorVerily Life Sciences, LLC20220—
+3K213409ZEUS System (Zio Watch)iRhythm Technologies, Inc.20220—