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47 FR 31142, July 16, 1982, unless otherwise noted.
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Nomenclature changes to part 868 appear at 73 FR 35341, June 23, 2008.
(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]