21 CFR 882.1835 — Amplifier, Physiological Signal
Neurology (NE) · Part 882 Subpart B—Neurological Diagnostic Devices · § 882.1835
Identification
A physiological signal amplifier is a general purpose device used to electrically amplify signals derived from various physiological sources (e.g., the electroencephalogram).
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GWL | Amplifier, Physiological Signal | 2 | 53 | 3rd Party |
