ISOFLO AND ISOTEC INTRAUTERINE PRESSURE MONITORING
Device Facts
| Record ID | K895763 |
|---|---|
| Device Name | ISOFLO AND ISOTEC INTRAUTERINE PRESSURE MONITORING |
| Applicant | Healthdyne Cardiovascular, Inc. |
| Product Code | KXO · Obstetrics/Gynecology |
| Decision Date | Dec 22, 1989 |
| 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.
