510(k) K991235

SOFTRANS TEMP INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS TEMP IUPC) by Ludlow Technical Products — Product Code KXO

K991235 is an FDA 510(k) premarket notification submitted by Ludlow Technical Products for the device "SOFTRANS TEMP INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS TEMP IUPC)". The FDA issued a decision of Substantially Equivalent on July 8, 1999. The device falls under product code KXO (Monitor, Pressure, Intrauterine), a Class II device regulated under 21 CFR 884.2700. Ludlow Technical Products has at least 4 other 510(k) clearances on record.