510(k) K873802

PRESSURE BARRIER KIT CAT. NO. PBK-3 by American Omni Medical, Inc. — Product Code DXS

K873802 is an FDA 510(k) premarket notification submitted by American Omni Medical, Inc. for the device "PRESSURE BARRIER KIT CAT. NO. PBK-3". The FDA issued a decision of Substantially Equivalent on November 6, 1987. The device falls under product code DXS (Gauge, Pressure, Coronary, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4310. American Omni Medical, Inc. has at least 10 other 510(k) clearances on record.