KXN · Monitor, Cardiac, Fetal
Obstetrics/Gynecology · 21 CFR 884.2600 · Class 2
Overview
| Product Code | KXN |
|---|---|
| Device Name | Monitor, Cardiac, Fetal |
| Regulation | 21 CFR 884.2600 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
| 3rd-Party Reviewable | Yes |
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.”
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K770245 | ABDOMINAL FETAL ECG MODULE | Mennen Greatbatch Electonics | Feb 14, 1977 | SESE |
| K760968 | CENTRAL STATION REPEATER (MODEL 8032A) | Hewlett-Packard Co. | Dec 17, 1976 | SESE |
Top Applicants
- Hewlett-Packard Co. — 1 clearance
- Mennen Greatbatch Electonics — 1 clearance
