GENESIS TM FETAL SYSTEM
Device Facts
| Record ID | K882084 |
|---|---|
| Device Name | GENESIS TM FETAL SYSTEM |
| Applicant | Pediatric Diagnostic Service |
| Product Code | HGM · Obstetrics/Gynecology |
| Decision Date | May 26, 1989 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.2740 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A perinatal monitoring system is a device used to show graphically the relationship between maternal labor and the fetal heart rate by means of combining and coordinating uterine contraction and fetal heart monitors with appropriate displays of the well-being of the fetus during pregnancy, labor, and delivery. This generic type of device may include any of the devices subject to §§ 884.2600, 884.2640, 884.2660, 884.2675, 884.2700, and 884.2720. This generic type of device may include the following accessories: Central monitoring system and remote repeaters, signal analysis and display equipment, patient and equipment supports, and component parts.
