21 CFR 882.1400 — Full-Montage Standard Electroencephalograph
Neurology (NE) · Part 882 Subpart B—Neurological Diagnostic Devices · § 882.1400
Identification
An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GWQ | Full-Montage Standard Electroencephalograph | 2 | 188 | SaMD, 3rd Party |
| OLT | Non-Normalizing Quantitative Electroencephalograph Software | 2 | 54 | SaMD, 3rd Party |
| OLU | Normalizing Quantitative Electroencephalograph Software | 2 | 12 | SaMD, 3rd Party |
| OLV | Standard Polysomnograph With Electroencephalograph | 2 | 64 | SaMD, 3rd Party |
| OLW | Index-Generating Electroencephalograph Software | 2 | 38 | SaMD |
| OLX | Source Localization Software For Electroencephalograph Or Magnetoencephalograph | 2 | 24 | SaMD, 3rd Party |
| OLY | Magnetoencephalograph | 2 | 6 | SaMD, 3rd Party |
| OLZ | Automatic Event Detection Software For Polysomnograph With Electroencephalograph | 2 | 36 | SaMD |
| OMA | Amplitude-Integrated Electroencephalograph | 2 | 16 | SaMD, 3rd Party |
| OMB | Automatic Event Detection Software For Full-Montage Electroencephalograph | 2 | 41 | SaMD |
| OMC | Reduced- Montage Standard Electroencephalograph | 2 | 28 | SaMD, 3rd Party |
| ORT | Burst Suppression Detection Software For Electroencephalograph | 2 | 1 | SaMD |
| SFK | Respiratory Effort Belt For Polysomnography | 2 | 1 |
