ABDOMINAL FETAL ECG MODULE
Device Facts
| Record ID | K770245 |
|---|---|
| Device Name | ABDOMINAL FETAL ECG MODULE |
| Applicant | Mennen Greatbatch Electonics |
| Product Code | KXN · Obstetrics/Gynecology |
| Decision Date | Feb 14, 1977 |
| 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.”
