510(k) Report

Devices descending from K946206

10 later devices reach Ciba Corning 8-- Series CO-Oximeter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K031560Bayer Rapidlab 1200 SystemBayer Healthcare, LLC2003114
+1K020616Bayer Rapidpoint 405 SystemBayer Diagnostics Corp.200224
+1K993837Avl Opti Critical Care AnalyzerAvl Scientific Corp.19992—
+1K984299Avl Opti Critical Care AnalyzerAvl Scientific Corp.19984—
+1K974784Avl Opti Critical Care AnalyzerAvl Scientific Corp.19985—
+1K972733Avl Omni AnalyzerAvl Scientific Corp.199706
+2K131126Opti Cca-TS2Opti Medical Systems, Inc.20131—
+2K113216Rapidpoint 500 Blood Gas AnalyerSiemens Healthcare Diagnostics2012012
+2K052027Opti Lion Electrolyte Analyzer, Model GD7200Osmetech, Inc.200504
+3K200986OPTI® B-Lac CassetteOpti Medical Systems, Inc.20210—