510(k) K002061

A&D MEDICAL TM-2550/TM-2551/TM-2560 VITAL SENSOR MONITOR by A&D Engineering, Inc. — Product Code DRT

K002061 is an FDA 510(k) premarket notification submitted by A&D Engineering, Inc. for the device "A&D MEDICAL TM-2550/TM-2551/TM-2560 VITAL SENSOR MONITOR". The FDA issued a decision of Substantially Equivalent on January 19, 2001. The device falls under product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)), a Class II device regulated under 21 CFR 870.2300. A&D Engineering, Inc. has at least 10 other 510(k) clearances on record.