21 CFR 882.1340 — Electrode, Nasopharyngeal
Neurology (NE) · Part 882 Subpart B—Neurological Diagnostic Devices · § 882.1340
Identification
A nasopharyngeal electrode is an electrode which is temporarily placed in the nasopharyngeal region for the purpose of recording electrical activity.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GZK | Electrode, Nasopharyngeal | 2 | 2 | 3rd Party |