510(k) K252463

SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E) by Edan Instruments, Inc. — Product Code DPS

K252463 is an FDA 510(k) premarket notification submitted by Edan Instruments, Inc. for the device "SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)". The FDA issued a decision of Substantially Equivalent on July 2, 2026. The device falls under product code DPS (Electrocardiograph), a Class II device regulated under 21 CFR 870.2340. Edan Instruments, Inc. has at least 10 other 510(k) clearances on record.