GZK
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Electrode, Nasopharyngeal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1340
- Medical specialty
- Neurology
- Flags
- Third-party review eligible
Download CSV table Client report (share link) ◉ Watch
Both buttons carry the same predicate table: the CSV downloads for your worksheet, the report is a shareable page for clients. Exports: 3 free/month with an account · reports & watching free.
Building a predicate table? Click + Add on candidates below (up to 8), then compare and export from your Builder.
| Record | Firm | Date | Builder |
|---|---|---|---|
| BALL RECORDING ELECTRODE/STIMULATION PROBE (K030517) | Viasys Healthcare, Inc. | 2003-08-01 | + Add |
| TIGER PULSE (K830325) | Bertone & Assoc. | 1983-03-01 | + Add |
Track GZK automatically
Every clearance here is in the API, with alerts when new ones post.