GYA · Tester, Electrode/Lead, Electroencephalograph
Neurology · 21 CFR 882.1410 · Class 1
Overview
| Product Code | GYA |
|---|---|
| Device Name | Tester, Electrode/Lead, Electroencephalograph |
| Regulation | 21 CFR 882.1410 |
| Device Class | Class 1 |
| Review Panel | Neurology |
Identification
An electroencephalograph electrode/lead tester is a device used for testing the impedance (resistance to alternating current) of the electrode and lead system of an electroencephalograph to assure that an adequate contact is made between the electrode and the skin.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.
Recent Cleared Devices (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K883869 | DERMTRODE | World Precision Instruments, Inc. | Sep 30, 1988 | SESE |
| K854396 | RUB E-Z | E-Z Instruments Co. | May 8, 1986 | SESE |
| K830877 | AP-CHECK | General Devices | Jun 8, 1983 | SESE |
| K820040 | SC-IT IMPEDANCE TESTER | Cadwell Laboratories, Inc. | Jan 28, 1982 | SESE |
| K781475 | ELECTRODE IMPEDANCE TESTER-MODEL 500 | Life-Tech Instruments, Inc. | Sep 7, 1978 | SESE |
Top Applicants
- Cadwell Laboratories, Inc. — 1 clearance
- E-Z Instruments Co. — 1 clearance
- General Devices — 1 clearance
- Life-Tech Instruments, Inc. — 1 clearance
- World Precision Instruments, Inc. — 1 clearance
