510(k) K885316
- Device
- Disposable Intrauterine Pressure Kit Model 13972a
- Applicant
- HEWLETT-PACKARD CO.
- 510(k) number
- K885316
- Product code
- KXO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-03-23
- Date received
- 1988-12-29
- Regulation
- 884.2700
- Classification name
- Monitor, Pressure, Intrauterine
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- VAN DEUSEN
- Address
- 3000 Minuteman Rd. Andover MA US 01810 01810
FDA Registration Numbers#
- 1718873
- 1921846
- 9681860
- 1423537
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KXO#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K991235 | SOFTRANS TEMP INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS TEMP IUPC) | Ludlow Technical Products | 1999-07-08 |
| K982565 | EASY TRANS TIP | Carl Schuh | 1998-09-22 |
| K974730 | SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUPC) | Graphic Controls Corp. | 1998-07-14 |
| K964279 | SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC) | Graphic Controls Corp. | 1997-01-22 |
| K961290 | IUP - TIP TRANS, IUP - PROXI TRANS | Scientific Device Manufacturer, LLC | 1996-10-15 |
| K950498 | LIFE TRACE TRANS TIP INTRAUTERINE PRESSURE CATHETER | Graphic Controls Corp. | 1995-07-24 |
| K950708 | LIFETRACE INTRAUTERINE PRESSURE CATHETER IUP 3000 | Graphic Controls Corp. | 1995-05-25 |
| K922323 | MX4042/MC4044 SERIES SIMULCATH(TM) | Medex, Inc. | 1994-06-14 |
| K920044 | DUAL LUMEN TRANSCERIVICAL INTRAUTERINE KIT | Telos Medical Corp. | 1992-04-03 |
| K910742 | MEDI-TRACE DISPOSABLE INTRAUTERINE CATHETER | Graphic Controls Corp. | 1992-01-14 |
| K905563 | INTRAN PLUS | Utah Medical Products, Inc. | 1991-06-19 |
| K910227 | MX4043---SERIES, INTRAUTERINE PRESSURE CATHETER | Medex, Inc. | 1991-04-03 |
| K901084 | ISOFLO INTRAUTERINE PRESSURE MONITORING & AMNIO. | Healthdyne Cardiovascular, Inc. | 1990-06-01 |
| K896122 | AMNICATHDL(TM) DT-IUPC2 DUAL LUMEN TRANS. TIPPED | Spectramed, Inc. | 1990-01-19 |
| K895763 | ISOFLO AND ISOTEC INTRAUTERINE PRESSURE MONITORING | Healthdyne Cardiovascular, Inc. | 1989-12-22 |