510(k) K895763

ISOFLO AND ISOTEC INTRAUTERINE PRESSURE MONITORING by Healthdyne Cardiovascular, Inc. — Product Code KXO

K895763 is an FDA 510(k) premarket notification submitted by Healthdyne Cardiovascular, Inc. for the device "ISOFLO AND ISOTEC INTRAUTERINE PRESSURE MONITORING". The FDA issued a decision of Substantially Equivalent on December 22, 1989. The device falls under product code KXO (Monitor, Pressure, Intrauterine), a Class II device regulated under 21 CFR 884.2700. Healthdyne Cardiovascular, Inc. has at least 4 other 510(k) clearances on record.