GZK · Electrode, Nasopharyngeal
Neurology · 21 CFR 882.1340 · Class 2
Overview
| Product Code | GZK |
|---|---|
| Device Name | Electrode, Nasopharyngeal |
| Regulation | 21 CFR 882.1340 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| 3rd-Party Reviewable | Yes |
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).
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K030517 | BALL RECORDING ELECTRODE/STIMULATION PROBE | Viasys Healthcare, Inc. | Aug 1, 2003 | SESE |
| K830325 | TIGER PULSE | Bertone & Assoc. | Mar 1, 1983 | SESE |
Top Applicants
- Bertone & Assoc. — 1 clearance
- Viasys Healthcare, Inc. — 1 clearance
