510(k) Report

Devices descending from K992323

4 later devices reach Datex-Ohmeda Cardiocap 5, F-MX, F-MXG and Accessories through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093881Trusignal SPO2 Finger Sensor, Trusignal SPO2 Ear Sensor, Trusignal SPO2 Wrap SensorGE Healthcare Finland Oy20102Class I
+1K012837Modification to: Datex-Ohmeda Cardiocap 5 (Rev B) and AccessoriesDatex-Ohmeda200102
+2K250931Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable SpO2…Unimed Medical Supplies, Inc.20250—
+2K132696Trusignal SPO2 Adult and Pediatric Adhesive Wrap Disposable SensorGE Healthcare Finland Oy20130—