§ 868.1040. Powered algesimeter.
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/us/cfr/t21/s§ 868.1040·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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]