510(k) K151329

SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNet by Sentec AG — Product Code LKD

K151329 is an FDA 510(k) premarket notification submitted by Sentec AG for the device "SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNet". The FDA issued a decision of Substantially Equivalent on December 17, 2015. The device falls under product code LKD (Monitor, Carbon-Dioxide, Cutaneous), a Class II device regulated under 21 CFR 868.2480. Sentec AG has at least 6 other 510(k) clearances on record.