510(k) Report

Devices descending from K971628

2 later devices reach Somanetics Invos 3100A Cerebral Oximeter (Invos) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111007Midwest Reprocessing Center Reprocessed LNCS Sessors; Midwest Reprocessing Center…Midwest Reprocessing Center, LLC20110—
+1K100523Adult Cerebral-Somatic Oximetry Sensor, Pediatric Cerebral-Somatic Oximetry Sensor Model…Hygia Health Services, Inc.20100—