21 CFR 868.5400 — Apparatus, Electronanesthesia
Anesthesiology (AN) · Part 868 Subpart F—Therapeutic Devices · § 868.5400
Identification
An electroanesthesia apparatus is a device used for the induction and maintenance of anesthesia during surgical procedures by means of an alternating or pulsed electric current that is passed through electrodes fixed to a patient's head.
Classification Rationale
Class III (premarket approval).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| BWL | Apparatus, Electronanesthesia | 3 | 0 |