510(k) K100129

AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X by Ambu A/S — Product Code DRX

K100129 is an FDA 510(k) premarket notification submitted by Ambu A/S for the device "AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X". The FDA issued a decision of Substantially Equivalent on June 11, 2010. The device falls under product code DRX (Electrode, Electrocardiograph), a Class II device regulated under 21 CFR 870.2360. Ambu A/S has at least 10 other 510(k) clearances on record.