510(k) K974389

KOALA INTRAUTERINE PRESSURE CATHETER, KOALA EXTERNAL INTRAUTERINE PRESSURE CATHETER by Clinical Innovations, Inc. — Product Code HFN

K974389 is an FDA 510(k) premarket notification submitted by Clinical Innovations, Inc. for the device "KOALA INTRAUTERINE PRESSURE CATHETER, KOALA EXTERNAL INTRAUTERINE PRESSURE CATHETER". The FDA issued a decision of Substantially Equivalent on February 19, 1998. The device falls under product code HFN (Transducer, Pressure, Intrauterine), a Class II device regulated under 21 CFR 884.2700. Clinical Innovations, Inc. has at least 10 other 510(k) clearances on record.