Telefactor D/EEG-32
by Grass-Telefactor Product Group
510(k) K925838
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK925838 | Date30 Apr 1993 | 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- Withdrawn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
- GWQ
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.1400
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Telefactor D/EEG-32 is a Full-Montage Standard Electroencephalograph, a diagnostic device designed to record electrical activity in the brain. It employs multiple electrodes placed on the scalp to detect and amplify brainwave patterns, enabling clinicians to diagnose and monitor neurological conditions such as epilepsy, sleep disorders, and other brain-related abnormalities.
This device is intended for use in clinical settings, including hospitals and neurology clinics, where trained professionals conduct EEG examinations. Supplied as a reusable medical instrument, it adheres to regulatory standards under FDA 510(k) clearance (K925838) and classification 882.1400. The device is not classified as MRI-safe or single-use, and its specifications include a product code GWQ. Storage and maintenance follow manufacturer guidelines to ensure proper functionality and sterility.