MODEL 8100 PRE-FILLED INTRAUTERINE
Device Facts
| Record ID | K790418 |
|---|---|
| Device Name | MODEL 8100 PRE-FILLED INTRAUTERINE |
| Applicant | Ge Medical Systems Information Technologies |
| Product Code | KXO · Obstetrics/Gynecology |
| Decision Date | Mar 21, 1979 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.2700 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An intrauterine pressure monitor is a device designed to detect and measure intrauterine and amniotic fluid pressure with a catheter placed transcervically into the uterine cavity. The device is used to monitor intensity, duration, and frequency of uterine contractions during labor. This generic type of device may include the following accessories: signal analysis and display equipment, patient and equipment supports, and component parts.
