K950708 is an FDA 510(k) clearance for the LIFETRACE INTRAUTERINE PRESSURE CATHETER IUP 3000. This device is classified as a Monitor, Pressure, Intrauterine (Class II - Special Controls, product code KXO).
Submitted by Graphic Controls Corp. (Buffalo, US). The FDA issued a Cleared decision on May 25, 1995, 101 days after receiving the submission on February 13, 1995.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.2700.
| 510(k) Number | K950708 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 13, 1995 |
| Decision Date | May 25, 1995 |
| Days to Decision | 101 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Statement |
| Product Code | KXO — Monitor, Pressure, Intrauterine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.2700 |