The following data is part of a premarket notification filed by Ludlow Technical Products with the FDA for Softrans Temp Intrauterine Pressure Catheter System (iup 5000, Softrans Temp Iupc).
| Device ID | K991235 |
| 510k Number | K991235 |
| Device Name: | SOFTRANS TEMP INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS TEMP IUPC) |
| Classification | Monitor, Pressure, Intrauterine |
| Applicant | LUDLOW TECHNICAL PRODUCTS TWO LUDLOW PARK Chicopee, MA 01022 |
| Contact | Kathleen M Murphy |
| Correspondent | Kathleen M Murphy LUDLOW TECHNICAL PRODUCTS TWO LUDLOW PARK Chicopee, MA 01022 |
| Product Code | KXO |
| CFR Regulation Number | 884.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-12 |
| Decision Date | 1999-07-08 |
| Summary: | summary |