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 CodeDevice NameClassDevicesAttributes
BWLApparatus, Electronanesthesia30
Innolitics

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