21 CFR 868.1040 — Algesimeter, Powered
Anesthesiology (AN) · Part 868 Subpart B—Diagnostic Devices · § 868.1040
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.
Classification Rationale
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| BSI | Algesimeter, Powered | 2 | 0 |
Special Controls
BSI — Algesimeter, Powered
*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.
eCFR
