510(k) Report

Devices descending from K101690

3 later devices reach Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with Digital Sensor… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232516Sentec Digital Monitoring System (SDMS) tCOM+Sentec AG20240—
+1K162014Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor Flexible SpO2…Bluepoint Medical GmbH & Co. KG20170—
+1K151329SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC…Sentec AG201519