21 C.F.R. · Food and Drugs
21 C.F.R. § 868.1040

Powered algesimeter.

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Regulatory Text

21 C.F.R. § 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]

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21 C.F.R. § 868.1040
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The regulatory text of 21 C.F.R. § 868.1040 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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boisestandard.org United States Law CFR Title 21 21 C.F.R. § 868.1040