510(k) K152944

Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems by Mortara Instrument, Inc. — Product Code DPS

K152944 is an FDA 510(k) premarket notification submitted by Mortara Instrument, Inc. for the device "Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems". The FDA issued a decision of Substantially Equivalent on January 6, 2016. The device falls under product code DPS (Electrocardiograph), a Class II device regulated under 21 CFR 870.2340. Mortara Instrument, Inc. has at least 10 other 510(k) clearances on record.