21 CFR 884.2620 — Monitor, Electroencephalographic, Fetal (And Accessories)
Obstetrics/Gynecology (OB) · Part 884 Subpart C—Obstetrical and Gynecological Monitoring Devices · § 884.2620
Identification
A fetal electroencephalographic monitor is a device used to detect, measure, and record in graphic form (by means of one or more electrodes placed transcervically on the fetal scalp during labor) the rhythmically varying electrical skin potentials produced by the fetal brain.
Classification Rationale
Class III (premarket approval).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HGO | Monitor, Electroencephalographic, Fetal (And Accessories) | 3 | 0 |
