Title 21

SECTION 868.1040

868.1040 Powered algesimeter.

§ 868.1040 Powered algesimeter.

(a) Identification. A powered algesimeter is a device using electrical stimulation intended to determine a patient's sensitivity to pain after administration of an anesthetic agent.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

[47 FR 31142, July 16, 1982, as amended at 84 FR 71811, Dec. 30, 2019]