HIQ · Electrode, Clip, Fetal Scalp (And Applicator)
Obstetrics/Gynecology · 21 CFR 884.2685 · Class 3
Overview
| Product Code | HIQ |
|---|---|
| Device Name | Electrode, Clip, Fetal Scalp (And Applicator) |
| Regulation | 21 CFR 884.2685 |
| Device Class | Class 3 |
| Review Panel | Obstetrics/Gynecology |
Identification
A fetal scalp clip electrode and applicator is a device designed to establish electrical contact between fetal skin and an external monitoring device by means of pinching skin tissue with a nonreusable clip. This device is used to obtain a fetal electrocardiogram. This generic type of device may include a clip electrode applicator.
Classification Rationale
Class III (premarket approval).
Recent Cleared Devices (0 of 0)
No cleared devices on record.
