510(k) Report

Devices descending from K043463

5 later devices reach Envitec Reusable Multi-Site Y SPO2 Sensors through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060675Envitec Reusable Softip Y SPO2 SensorsEnvitec-Wismar GmbH20064—
+2K101690Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with Digital Sensor Adaper CableSentec AG2010312
+3K232516Sentec Digital Monitoring System (SDMS) tCOM+Sentec AG20240—
+3K162014Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor Flexible SpO2…Bluepoint Medical GmbH & Co. KG20170—
+3K151329SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC…Sentec AG201519