510(k) Report

Devices descending from K004007

2 later devices reach DR180+OXY through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081861Holter LX AnalysisNorth East Monitoring, Inc.20080—
+1K051686Cardiomem CM 3000-12Getemed Medizin- Und Informationstechnik AG20050—