510(k) Report

Devices descending from K062090

2 later devices reach Prisma System R03.10A through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110823PrismaflexGambro Renal Products, Inc.201119
+2K170790SAM CRRT Unit, SAM Cassette CRRTSpectral Medical, Inc.20170—