BSI · Algesimeter, Powered
Anesthesiology · 21 CFR 868.1040 · Class 2
Overview
| Product Code | BSI |
|---|---|
| Device Name | Algesimeter, Powered |
| Regulation | 21 CFR 868.1040 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
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.
Special Controls
*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.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
