FDA 510(k) Applications for Medical Device Product Code "KXO"
(Monitor, Pressure, Intrauterine)

FDA 510(k) Number Applicant Device Name Decision Date
K982565 CARL SCHUH EASY TRANS TIP 09/22/1998
K964279 GRAPHIC CONTROLS CORP. SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC) 01/22/1997
K974730 GRAPHIC CONTROLS CORP. SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUPC) 07/14/1998
K991235 LUDLOW TECHNICAL PRODUCTS SOFTRANS TEMP INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS TEMP IUPC) 07/08/1999
K961290 SCIENTIFIC DEVICE MANUFACTURER LLC. IUP - TIP TRANS, IUP - PROXI TRANS 10/15/1996


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