510(k) K792602

SUSI II PACEMAKER SURVEILLANCE MONITOR by Ela Medical, Inc. — Product Code DTC

K792602 is an FDA 510(k) premarket notification submitted by Ela Medical, Inc. for the device "SUSI II PACEMAKER SURVEILLANCE MONITOR". The FDA issued a decision of Substantially Equivalent on March 25, 1980. The device falls under product code DTC (Analyzer, Pacemaker Generator Function), a Class II device regulated under 21 CFR 870.3630. Ela Medical, Inc. has at least 10 other 510(k) clearances on record.