510(k) K863702

PULSE CUFF RECORDER MODEL PCR100 by Imex Medical Systems, Inc. — Product Code JOM

K863702 is an FDA 510(k) premarket notification submitted by Imex Medical Systems, Inc. for the device "PULSE CUFF RECORDER MODEL PCR100". The FDA issued a decision of Substantially Equivalent on June 12, 1987. The device falls under product code JOM (Plethysmograph, Photoelectric, Pneumatic Or Hydraulic), a Class II device regulated under 21 CFR 870.2780. Imex Medical Systems, Inc. has at least 10 other 510(k) clearances on record.