21 CFR 882.1550 — Device, Nerve Conduction Velocity Measurement
Neurology (NE) · Part 882 Subpart B—Neurological Diagnostic Devices · § 882.1550
Identification
A nerve conduction velocity measurement device is a device which measures nerve conduction time by applying a stimulus, usually to a patient's peripheral nerve. This device includes the stimulator and the electronic processing equipment for measuring and displaying the nerve conduction time.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| JXE | Device, Nerve Conduction Velocity Measurement | 2 | 27 | 3rd Party |
