510(k) K041548

SENTEC DIGITAL MONITOR MODEL #SDM by Sentec, Inc. — Product Code LKD

K041548 is an FDA 510(k) premarket notification submitted by Sentec, Inc. for the device "SENTEC DIGITAL MONITOR MODEL #SDM". The FDA issued a decision of Substantially Equivalent on August 9, 2004. The device falls under product code LKD (Monitor, Carbon-Dioxide, Cutaneous), a Class II device regulated under 21 CFR 868.2480. Sentec, Inc. has at least 6 other 510(k) clearances on record.