CENTRAL STATION REPEATER (MODEL 8032A)
Device Facts
| Record ID | K760968 |
|---|---|
| Device Name | CENTRAL STATION REPEATER (MODEL 8032A) |
| Applicant | Hewlett-Packard Co. |
| Product Code | KXN · Obstetrics/Gynecology |
| Decision Date | Dec 17, 1976 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.2600 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A fetal cardiac monitor is a device used to ascertain fetal heart activity during pregnancy and labor. The device is designed to separate fetal heart signals from maternal heart signals by analyzing electrocardiographic signals (electrical potentials generated during contraction and relaxation of heart muscle) obtained from the maternal abdomen with external electrodes. This generic type of device may include an alarm that signals when the heart rate crosses a preset threshold. This generic type of device includes the “fetal cardiotachometer (with sensors)” and the “fetal electrocardiographic monitor.”
