510(k) K012141

AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE by External Counterpulsation Lab — Product Code DRN

K012141 is an FDA 510(k) premarket notification submitted by External Counterpulsation Lab for the device "AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE". The FDA issued a decision of Substantially Equivalent on October 25, 2001. The device falls under product code DRN (Device, Counter-Pulsating, External), a Class II device regulated under 21 CFR 870.5225. External Counterpulsation Lab has at least 1 other 510(k) clearance on record.