Tester, Electrode/Lead, Electroencephalograph
The Electroencephalograph Electrode/Lead Tester is a diagnostic accessory used to verify the integrity and function of EEG electrodes and their lead connections before or during electroencephalographic recording procedures. It is classified as a Class 1 device (lowest risk), subject to general controls only. The product code is GYA under regulation 21 CFR 882.1410 in the Neurology specialty. No implant, life-sustaining, GMP exempt, or third-party review flags apply.
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Basic Information
- Product Code
- GYA
- Device Class
- FDA class 1
- Regulation Number
- 882.1410
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K883869 | DERMTRODE | Sep 30, 1988 | Substantially Equivalent | World Precision Instruments, Inc. |
| K854396 | RUB E-Z | May 08, 1986 | Substantially Equivalent | E-Z Instruments Co. |
| K830877 | AP-CHECK | Jun 08, 1983 | Substantially Equivalent | General Devices |
| K820040 | SC-IT IMPEDANCE TESTER | Jan 28, 1982 | Substantially Equivalent | Cadwell Laboratories, Inc. |
| K781475 | ELECTRODE IMPEDANCE TESTER-MODEL 500 | Sep 07, 1978 | Substantially Equivalent | Life-Tech Instruments, Inc. |
FEI Numbers
This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.