510(k) Report

Devices descending from K981270

4 later devices reach Irma Blood Analysis System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K013624Modification to Agilent Component Monitoring System (CMS), V24/V26 Patient Monitors…Philips Medizin Systeme Boblingen GmbH20010—
+1K993837Avl Opti Critical Care AnalyzerAvl Scientific Corp.19992—
+2K131126Opti Cca-TS2Opti Medical Systems, Inc.20131—
+3K200986OPTI® B-Lac CassetteOpti Medical Systems, Inc.20210—