510(k) K101690

SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLE by Sentec AG — Product Code LKD

K101690 is an FDA 510(k) premarket notification submitted by Sentec AG for the device "SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLE". The FDA issued a decision of Substantially Equivalent on December 3, 2010. 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.