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e-CFR data is current as of January 19, 2021 |
Title 21 → Chapter I → Subchapter H → Part 868 → Subpart B → §868.1040 |
Title 21: Food and Drugs
PART 868—ANESTHESIOLOGY DEVICES
Subpart B—Diagnostic Devices
§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]