510(k) Report

Devices descending from K142512

3 later devices reach Personalized Physiology Analytics Engine software through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183282Biovitals Analytics EngineBiofourmis Singapore Pte., Ltd.20192—
+2K230386SpassageQSpass, Inc.20231—
+3K240558NavoycdsAlgodx AB20240—