510(k) Report

Devices descending from K212153

5 later devices reach Biobeat Platform, BB-613WP Patch through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.20242—
+1K222010Biobeat Platform-2 and BB-613WP PatchBiobeat Technologies, Ltd.20221—
+2K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.20260—
+2K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC20260—
+2K241066BB-613-BPMBiobeat Technologies, Ltd.20250—