510(k) K885316

DISPOSABLE INTRAUTERINE PRESSURE KIT MODEL 13972A by Hewlett-Packard Co. — Product Code KXO

K885316 is an FDA 510(k) premarket notification submitted by Hewlett-Packard Co. for the device "DISPOSABLE INTRAUTERINE PRESSURE KIT MODEL 13972A". The FDA issued a decision of Substantially Equivalent on March 23, 1989. The device falls under product code KXO (Monitor, Pressure, Intrauterine), a Class II device regulated under 21 CFR 884.2700. Hewlett-Packard Co. has at least 10 other 510(k) clearances on record.