21 C.F.R. § 868.5400 Electroanesthesia apparatus.
Title 21 - Food and Drugs
(a) 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. (b) Classification. Class III (premarket approval). (c) Date PMA or notice of completion of a PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any electroanesthesia apparatus that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to an electroanesthesia apparatus that was in commercial distribution before May 28, 1976. Any other electroanesthesia apparatus shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution. [47 FR 31142, July 16, 1982, as amended at 52 FR 17735, May 11, 1987; 61 FR 50706, Sept. 27, 1996]
Title 21: Food and Drugs
PART 868—ANESTHESIOLOGY DEVICES
Subpart F—Therapeutic Devices
§ 868.5400 Electroanesthesia apparatus.
