510(k) K832369

VASCULAR RECORDER #301 by Imex Medical Systems, Inc. — Product Code JOP

K832369 is an FDA 510(k) premarket notification submitted by Imex Medical Systems, Inc. for the device "VASCULAR RECORDER #301". The FDA issued a decision of Substantially Equivalent on March 12, 1984. The device falls under product code JOP (Transducer, Ultrasonic), a Class II device regulated under 21 CFR 870.2880. Imex Medical Systems, Inc. has at least 10 other 510(k) clearances on record.