Ear Electrode-Adult & Pediatric
by Life-Tech Instruments, Inc.
510(k) K780537
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK780537 | Date2 Jun 1978 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- GXY
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.1320
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 21 Sep 2026
The Ear Electrode-Adult & Pediatric is a neurology device designed to record electrophysiological signals from the ear in both adult and pediatric patients. It functions as an electrode for electroencephalographic or related monitoring applications.
The device is marketed by Life-Tech Instruments, Inc. and was cleared through the FDA 510(k) Traditional pathway (K780537) as a Class 2 neurology device with product code GXY. It was deemed substantially equivalent to a predicate device and received clearance on June 2, 1978. The electrode is supplied by the manufacturer for clinical use; no specific sterility, single‑use, or MRI safety information is provided in the available data.
Other devices from Life-Tech Instruments, Inc.
Questions
AI-generated answers, 21 Sep 2026
What is the Ear Electrode-Adult & Pediatric used for?
The Ear Electrode-Adult & Pediatric is designed to record electrophysiological signals from the ear in both adult and pediatric patients. It functions as an electrode for electroencephalographic or related monitoring applications, enabling clinicians to capture neurological data during diagnostic procedures.
How is the Ear Electrode-Adult & Pediatric supplied and is it sterile or single-use?
The device is supplied by Life-Tech Instruments, Inc. for clinical use. The available data does not specify whether the electrode is sterile, single-use, or reusable, so users should consult the manufacturer's labeling or instructions for use for detailed information on handling, sterility, and reuse policies.
What regulatory pathway was used for the Ear Electrode-Adult & Pediatric and what is its classification?
The Ear Electrode-Adult & Pediatric was cleared through the FDA 510(k) Traditional pathway under submission K780537. It is classified as a Class 2 neurology device with product code GXY, and was deemed substantially equivalent to a predicate device, receiving clearance on June 2, 1978.