510(k) K071672

SENTEC DIGITAL MONITORING SYSTEM by Sentec AG — Product Code DQA

K071672 is an FDA 510(k) premarket notification submitted by Sentec AG for the device "SENTEC DIGITAL MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on September 12, 2007. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Sentec AG has at least 6 other 510(k) clearances on record.