21 CFR 882.1880 — Stimulator, Mechanical, Evoked Response
Neurology (NE) · Part 882 Subpart B—Neurological Diagnostic Devices · § 882.1880
Identification
An evoked response mechanical stimulator is a device used to produce a mechanical stimulus or a series of mechanical stimuli for the purpose of measuring a patient's evoked response.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GZP | Stimulator, Mechanical, Evoked Response | 2 | 2 | 3rd Party |
