510(k) Report

Devices descending from K954482

6 later devices reach Sendx 100 PH, Blood Gas & Electrolyte Analysis System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K993837Avl Opti Critical Care AnalyzerAvl Scientific Corp.19992—
+1K984299Avl Opti Critical Care AnalyzerAvl Scientific Corp.19984—
+1K974784Avl Opti Critical Care AnalyzerAvl Scientific Corp.19985—
+2K131126Opti Cca-TS2Opti Medical Systems, Inc.20131—
+2K052027Opti Lion Electrolyte Analyzer, Model GD7200Osmetech, Inc.200504
+3K200986OPTI® B-Lac CassetteOpti Medical Systems, Inc.20210—