510(k) Report

Devices descending from K182073

2 later devices reach BcSs-PICNI-2000 Sensor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201989B4C SystemBraincare Desenvolvimento E Inovacao Tecnologica S.A.20211—
+2K240821B4C System - Addition of new sensor model (BcSs-PICNIW-2000)Braincare Desenvolvimento E Inovação Tecnológica S.A.20240—