GYA
5 FDA 510(k) clearances · Product code
21 daysmedian time to decision
189 days90th percentile
5clearances measured
FDA profile
- Official device name
- Tester, Electrode/Lead, Electroencephalograph
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 882.1410
- Medical specialty
- Neurology
- Adverse events (MAUDE)
- 1992: 1 · 1995: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| DERMTRODE (K883869) | World Precision Instruments, Inc. | 1988-09-30 |
| RUB E-Z (K854396) | E-Z Instruments Co. | 1986-05-08 |
| AP-CHECK (K830877) | General Devices | 1983-06-08 |
| SC-IT IMPEDANCE TESTER (K820040) | Cadwell Laboratories, Inc. | 1982-01-28 |
| ELECTRODE IMPEDANCE TESTER-MODEL 500 (K781475) | Life-Tech Instruments, Inc. | 1978-09-07 |
Track GYA automatically
Every clearance here is in the API, with alerts when new ones post.