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21 CFR 868.1040

§ 868.1040 Powered algesimeter.

United States · 21 CFR — Food and Drugs · Status: effective

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21 CFR 868.1040, § 868.1040 Powered algesimeter, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89708
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(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.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.