KXO — Monitor, Pressure, Intrauterine Class II
FDA Device Classification
Classification Details
- Product Code
- KXO
- Device Class
- Class II
- Regulation Number
- 884.2700
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K991235 | ludlow technical products | SOFTRANS TEMP INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS TEMP IUP | July 8, 1999 |
| K982565 | carl schuh | EASY TRANS TIP | September 22, 1998 |
| K974730 | graphic controls | SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUP | July 14, 1998 |
| K964279 | graphic controls | SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC) | January 22, 1997 |
| K961290 | scientific device manufacturer | IUP - TIP TRANS, IUP - PROXI TRANS | October 15, 1996 |
| K950498 | graphic controls | LIFE TRACE TRANS TIP INTRAUTERINE PRESSURE CATHETER | July 24, 1995 |
| K950708 | graphic controls | LIFETRACE INTRAUTERINE PRESSURE CATHETER IUP 3000 | May 25, 1995 |
| K922323 | medex | MX4042/MC4044 SERIES SIMULCATH(TM) | June 14, 1994 |
| K920044 | telos medical | DUAL LUMEN TRANSCERIVICAL INTRAUTERINE KIT | April 3, 1992 |
| K910742 | graphic controls | MEDI-TRACE DISPOSABLE INTRAUTERINE CATHETER | January 14, 1992 |
| K905563 | utah medical products | INTRAN PLUS | June 19, 1991 |
| K910227 | medex | MX4043---SERIES, INTRAUTERINE PRESSURE CATHETER | April 3, 1991 |
| K901084 | healthdyne cardiovascular | ISOFLO INTRAUTERINE PRESSURE MONITORING & AMNIO. | June 1, 1990 |
| K896122 | spectramed | AMNICATHDL(TM) DT-IUPC2 DUAL LUMEN TRANS. TIPPED | January 19, 1990 |
| K895763 | healthdyne cardiovascular | ISOFLO AND ISOTEC INTRAUTERINE PRESSURE MONITORING | December 22, 1989 |
| K895323 | spectramed | MODEL DT-BAL, BALANCE SAVER | October 24, 1989 |
| K894362 | spectramed | MODEL DT-IUPC2 TRANSDUCER TIPPED DUAL LUMEN IUP | August 15, 1989 |
| K885316 | hewlett-packard | DISPOSABLE INTRAUTERINE PRESSURE KIT MODEL 13972A | March 23, 1989 |
| K881857 | spectramed | AMNICATH(TM) MODEL DT-IUPC TRANS. TIPPED INTRAU. | February 1, 1989 |
| K883832 | telos medical | CATHETER, INTRAUTERINE AND INTRODUCER | December 13, 1988 |